Trial Outcomes & Findings for Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery. (NCT NCT03584373)
NCT ID: NCT03584373
Last Updated: 2023-12-18
Results Overview
The patient will be administered a survey and asked to rate satisfaction with pain relief since the time of surgery and being on the assigned medication. Scoring will be on an 11-point ordinal numeric rating scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied. Higher scores are indicative of greater satisfaction with pain relief
COMPLETED
PHASE3
119 participants
1 week post surgery
2023-12-18
Participant Flow
Patients scheduled for surgery between July 2018 and May 2021 were consented and enrolled into the study.
A total of 119 patients were consented and enrolled into the study. Of the 119 patients, 14 patients screen failed (did not meet inclusion/exclusion criteria) and were not randomized into the study. Accordingly, 105 patients were randomized into the two arms/groups for this study.
Participant milestones
| Measure |
Non-Opioid Analgesia
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
54
|
|
Overall Study
COMPLETED
|
44
|
46
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Non-Opioid Analgesia
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
Baseline Characteristics
Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
Baseline characteristics by cohort
| Measure |
Non-Opioid Analgesia
n=51 Participants
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=54 Participants
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
47 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
48 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
22 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
54 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.0 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
29.1 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Participants with Percutaneous Nephrolithotomy (PCNL) Surgeries
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Stent Placement During Procedure
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Prior Kidney Stone Removal Surgery
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Average Stone Burden
|
10.9 millimeters
STANDARD_DEVIATION 4.5 • n=5 Participants
|
18.1 millimeters
STANDARD_DEVIATION 12.1 • n=7 Participants
|
14.7 millimeters
STANDARD_DEVIATION 9.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week post surgeryPopulation: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
The patient will be administered a survey and asked to rate satisfaction with pain relief since the time of surgery and being on the assigned medication. Scoring will be on an 11-point ordinal numeric rating scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied. Higher scores are indicative of greater satisfaction with pain relief
Outcome measures
| Measure |
Non-Opioid Analgesia
n=44 Participants
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=46 Participants
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Satisfaction With Pain Relief
|
8.70 score on a scale
Standard Deviation 2.01
|
8.85 score on a scale
Standard Deviation 1.49
|
PRIMARY outcome
Timeframe: 1 week post surgeryPopulation: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
The patient will be administered a survey and asked to rate their current pain intensity level (1 week post surgery) on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of greater pain intensity.
Outcome measures
| Measure |
Non-Opioid Analgesia
n=44 Participants
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=46 Participants
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Current Pain Intensity Level
|
1.14 score on a scale
Standard Deviation 1.94
|
1.37 score on a scale
Standard Deviation 2.08
|
PRIMARY outcome
Timeframe: 1 week post surgeryPopulation: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
The patient will be administered a survey and asked to rate the worst/peak pain intensity level since undergoing the surgery. The patient will be asked to rate this worst pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scoring is indicative of worst/peak pain intensity level since the time of surgery
Outcome measures
| Measure |
Non-Opioid Analgesia
n=44 Participants
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=46 Participants
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Peak Pain Intensity Level
|
5.61 score on a scale
Standard Deviation 3.41
|
7.52 score on a scale
Standard Deviation 3.00
|
PRIMARY outcome
Timeframe: 1 week post surgeryPopulation: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
The patient will be administered a survey and asked to rate their average pain intensity level since undergoing surgery. The patient will be asked to rate this average pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of higher average pain intensity.
Outcome measures
| Measure |
Non-Opioid Analgesia
n=44 Participants
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=46 Participants
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Average Pain Intensity Level
|
3.34 score on a scale
Standard Deviation 2.57
|
4.50 score on a scale
Standard Deviation 2.69
|
PRIMARY outcome
Timeframe: 1 week post surgeryPopulation: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
The patient will be administered a survey and asked to rate what their perception or belief of an acceptable pain intensity level would be since undergoing the surgery. The patient will be asked to rate this acceptable pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 equaling no pain, and 10 being the worst possible pain. Higher scores are indicative of the patient's belief of an acceptable pain intensity level.
Outcome measures
| Measure |
Non-Opioid Analgesia
n=44 Participants
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=46 Participants
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Perception of an Acceptable Pain Intensity Level
|
2.73 score on a scale
Standard Deviation 2.48
|
3.28 score on a scale
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: 1 week post surgeryPopulation: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
Unused medications is defined as the proportion of prescribed pills that were unused at 1 week post surgery as reported by the patient. More unused medications may indicate the potential to decrease the dosage needed.
Outcome measures
| Measure |
Non-Opioid Analgesia
n=44 Participants
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=46 Participants
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery
|
0.63 proportion of unused pills
Standard Deviation 0.37
|
0.58 proportion of unused pills
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 1 week post surgeryPopulation: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
Percentage of patients who experienced constipation any time during the week after surgery. A lower percentage of constipation may indicate less incidence of adverse events.
Outcome measures
| Measure |
Non-Opioid Analgesia
n=44 Participants
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=46 Participants
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Rates of Constipation
|
11 Participants
|
17 Participants
|
Adverse Events
Non-Opioid Analgesia
Opioid Analgesia
Serious adverse events
| Measure |
Non-Opioid Analgesia
n=51 participants at risk
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=54 participants at risk
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/51 • Up to 1 week postoperatively
|
1.9%
1/54 • Number of events 1 • Up to 1 week postoperatively
|
|
General disorders
Fever
|
2.0%
1/51 • Number of events 1 • Up to 1 week postoperatively
|
1.9%
1/54 • Number of events 1 • Up to 1 week postoperatively
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/51 • Up to 1 week postoperatively
|
3.7%
2/54 • Number of events 2 • Up to 1 week postoperatively
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/51 • Up to 1 week postoperatively
|
5.6%
3/54 • Number of events 3 • Up to 1 week postoperatively
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
2.0%
1/51 • Number of events 1 • Up to 1 week postoperatively
|
0.00%
0/54 • Up to 1 week postoperatively
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.0%
1/51 • Number of events 1 • Up to 1 week postoperatively
|
0.00%
0/54 • Up to 1 week postoperatively
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
2.0%
1/51 • Number of events 1 • Up to 1 week postoperatively
|
0.00%
0/54 • Up to 1 week postoperatively
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • Number of events 1 • Up to 1 week postoperatively
|
0.00%
0/54 • Up to 1 week postoperatively
|
Other adverse events
| Measure |
Non-Opioid Analgesia
n=51 participants at risk
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).
Acetaminophen - Oral; patient directed as needed. Not prescribed.
Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.
Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
|
Opioid Analgesia
n=54 participants at risk
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).
Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.
Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/51 • Up to 1 week postoperatively
|
1.9%
1/54 • Number of events 1 • Up to 1 week postoperatively
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Number of events 1 • Up to 1 week postoperatively
|
0.00%
0/54 • Up to 1 week postoperatively
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/51 • Number of events 1 • Up to 1 week postoperatively
|
0.00%
0/54 • Up to 1 week postoperatively
|
Additional Information
Dr. Kara Watts, Associate Professor, Department of Urology
Montefiore Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place