Trial Outcomes & Findings for Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma (NCT NCT04495894)
NCT ID: NCT04495894
Last Updated: 2025-03-04
Results Overview
Hemorrhagic side effects among participants receiving ketorolac preoperatively will be assessed as the need for blood transfusions before being discharged from the hospital after surgery. The need for a blood transfusion is defined as needing two or more units of blood, which are not related to vascular injury due to technical considerations or complications, as determined by the operating surgeon.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Prior to Hospital Discharge (up to 13 days post surgery)
Results posted on
2025-03-04
Participant Flow
Participants were recruited from the Emory Clinic, Emory University Hospital Midtown, Emory University Hospital, and the Winship Cancer Institute in Atlanta, Georgia, USA. Participant enrollment began August 24, 2020 the final study assessment occurred February 1, 2024.
Participant milestones
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
6
|
33
|
13
|
|
Overall Study
Participants Who Started the Study Activities of Ketorolac Administration (if Assigned) and Surgery
|
14
|
6
|
28
|
10
|
|
Overall Study
COMPLETED
|
14
|
6
|
28
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
5
|
3
|
Reasons for withdrawal
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
3
|
|
Overall Study
Early termination
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=14 Participants
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=6 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
n=28 Participants
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
n=10 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
62.2 years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Prior to Hospital Discharge (up to 13 days post surgery)Hemorrhagic side effects among participants receiving ketorolac preoperatively will be assessed as the need for blood transfusions before being discharged from the hospital after surgery. The need for a blood transfusion is defined as needing two or more units of blood, which are not related to vascular injury due to technical considerations or complications, as determined by the operating surgeon.
Outcome measures
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=14 Participants
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=6 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
n=28 Participants
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
n=10 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Number of Participants Receiving a Blood Transfusion
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Prior to Hospital Discharge (up to 13 days post surgery)Post-surgical significant hematoma development is assessed as the number of participants experiencing a hematoma prior to hospital discharge.
Outcome measures
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=14 Participants
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=6 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
n=28 Participants
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
n=10 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Clinically Significant Hematoma Development
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Prior to Hospital Discharge (up to 13 days post surgery)Post-operative bleeding is assessed at the number of participants needing to return to the operating room for bleeding, as determined by the treating surgeon.
Outcome measures
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=14 Participants
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=6 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
n=28 Participants
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
n=10 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Number of Participants Returning to the Operating Room for Bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Prior to Hospital Discharge (up to 13 days post surgery)Postoperative renal failure is assessed as the number of participants experiencing renal failure prior to hospital discharge.
Outcome measures
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=14 Participants
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=6 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
n=28 Participants
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
n=10 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Postoperative Renal Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Prior to Hospital Discharge (up to 13 days post surgery)Postoperative morbidity is assessed as the count of participants experiencing at least one adverse event or serious adverse event from surgery to hospital discharge.
Outcome measures
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=14 Participants
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=6 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
n=28 Participants
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
n=10 Participants
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Postoperative Morbidity
|
6 Participants
|
1 Participants
|
14 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28Transcriptome analysis will be performed to evaluate the effects of ketorolac on immune response pathways.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28Flow Cytometry will be performed to evaluate the effects of ketorolac on immune response pathways.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28T-Cell receptor (TCR) sequencing will be performed to evaluate the effects of ketorolac on immune response pathways.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28Single cell RNA sequencing will be performed to evaluate the effects of ketorolac on immune response pathways.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28IL-1alpha levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28IL-1beta levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28IL-2 levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28IL-6 levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28IL-8 levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28IL-10 levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28IL-12p70 levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28TNF-alpha levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28INF-gamma levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28GM-CSF levels will be compared between study arms.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 1, Day 3 (if admitted to hospital), Day 7, Day 28MCAF levels will be compared between study arms.
Outcome measures
Outcome data not reported
Adverse Events
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Control Group For Participants With Renal Cell Carcinoma (RCC)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=14 participants at risk
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=6 participants at risk
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
n=28 participants at risk
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
n=10 participants at risk
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Hypotension
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Cardiac disorders
Elevated cardiac troponin
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
14.3%
2/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
Subcutaneous emphysema
|
7.1%
1/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
Other adverse events
| Measure |
Preoperative Ketorolac For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=14 participants at risk
Participants randomized to receive ketorolac prior to surgery for stage I/II non-small cell lung carcinoma (NSCLC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Non-small Cell Lung Carcinoma (NSCLC)
n=6 participants at risk
Participants randomized to the control group receiving the standard of care during surgery for stage I/II non-small cell lung carcinoma (NSCLC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
Preoperative Ketorolac For Participants With Renal Cell Carcinoma (RCC)
n=28 participants at risk
Participants randomized to receive ketorolac prior to surgery for stage III renal cell carcinoma (RCC). Participants receive standard-of-care surgery. Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered.
Preoperative Ketorolac: 30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
|
Control Group For Participants With Renal Cell Carcinoma (RCC)
n=10 participants at risk
Participants randomized to the control group receiving the standard of care during surgery for stage III renal cell carcinoma (RCC). Open, video-assisted thoracic surgery, laparoscopy, or robotic surgery are allowed. Standard anesthesia is administered. The concurrent control group is to obtain untreated biologic samples for biologic correlative studies and secondary endpoints.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hematoma
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
7.1%
2/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Blood and lymphatic system disorders
Thrombophlebitis
|
7.1%
1/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Blood and lymphatic system disorders
Hypertension
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Blood and lymphatic system disorders
Hypotension
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
14.3%
4/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.7%
3/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Nausea/vomiting
|
7.1%
1/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
35.7%
10/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
60.0%
6/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Esophagitis
|
7.1%
1/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Belching/bloating
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.7%
3/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
20.0%
2/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.7%
3/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
7.1%
2/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Dizziness
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Allergic reaction to oxycodone
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Edema
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Fever
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
7.1%
2/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
External ear pain
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Eye irritation
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Fatigue
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Itching
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
20.0%
2/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Tremor
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
7.1%
2/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Infections and infestations
Wound infection
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
General disorders
Numbness (right hand)
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
7.1%
2/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
High chest tube output
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
16.7%
1/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
Persistent air leak
|
7.1%
1/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
21.4%
3/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
16.7%
1/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
7.1%
2/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.7%
3/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Musculoskeletal and connective tissue disorders
Rib cage pain
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Renal and urinary disorders
Low urine output
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
3.6%
1/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/14 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/6 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
0.00%
0/28 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
10.0%
1/10 • Information about adverse events was collected from the time of the preoperative visit through 28 days after surgery (up to 141 days), from participants who began study activities (had their standard of care surgery, and were administered ketorolac if they were randomized to the ketorolac study arm).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place