Trial Outcomes & Findings for Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients (NCT NCT00225732)
NCT ID: NCT00225732
Last Updated: 2016-06-22
Results Overview
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
319 participants
Primary outcome timeframe
24 Hours
Results posted on
2016-06-22
Participant Flow
Participants were recruited from the medical practices and/or clinics of the investigator/sub-investigators.
A total of 319 participants were randomized into two treatment groups. Randomized participants were additionally stratified by age and weight; three participants were randomized to incorrect stratification categories. All 319 participants received at least one dose of clinical trial material.
Participant milestones
| Measure |
Placebo
The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
800 mg Intravenous Ibuprofen
The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
166
|
|
Overall Study
COMPLETED
|
153
|
166
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=153 Participants
The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
800 mg Intravenous Ibuprofen
n=166 Participants
The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
Total
n=319 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than or equal to 45 years
|
104 participants
n=5 Participants
|
110 participants
n=7 Participants
|
214 participants
n=5 Participants
|
|
Age, Customized
45 to 70 years of age
|
49 participants
n=5 Participants
|
56 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
52 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
91 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=5 Participants
|
166 participants
n=7 Participants
|
319 participants
n=5 Participants
|
|
Weight
Less than or equal to 75 kilograms
|
57 Kilograms
n=5 Participants
|
61 Kilograms
n=7 Participants
|
118 Kilograms
n=5 Participants
|
|
Weight
Greater than 75 kilograms
|
96 Kilograms
n=5 Participants
|
105 Kilograms
n=7 Participants
|
201 Kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 HoursChange in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery
Outcome measures
| Measure |
Placebo
n=153 Participants
The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
800 mg Intravenous Ibuprofen
n=166 Participants
The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
|---|---|---|
|
Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery
|
57.0 milligrams
Standard Error 2.4
|
48.7 milligrams
Standard Error 2.3
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 149 other events
Deaths: 0 deaths
800 mg Intravenous Ibuprofen
Serious events: 12 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=153 participants at risk
The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
800 mg Intravenous Ibuprofen
n=166 participants at risk
The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
|---|---|---|
|
Investigations
Oxygen saturation decreased
|
0.65%
1/153 • Number of events 1 • 14 Days
|
0.00%
0/166 • 14 Days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
2/153 • Number of events 2 • 14 Days
|
0.00%
0/166 • 14 Days
|
|
Gastrointestinal disorders
Ileus
|
0.65%
1/153 • Number of events 1 • 14 Days
|
1.8%
3/166 • Number of events 3 • 14 Days
|
|
Gastrointestinal disorders
Peritoneal Hemorrhage
|
0.65%
1/153 • Number of events 1 • 14 Days
|
0.00%
0/166 • 14 Days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.65%
1/153 • Number of events 1 • 14 Days
|
0.00%
0/166 • 14 Days
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Injury, poisoning and procedural complications
Wound Dihisence
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
|
Vascular disorders
Hematoma
|
0.00%
0/153 • 14 Days
|
0.60%
1/166 • Number of events 1 • 14 Days
|
Other adverse events
| Measure |
Placebo
n=153 participants at risk
The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
800 mg Intravenous Ibuprofen
n=166 participants at risk
The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
55.6%
85/153 • Number of events 132 • 14 Days
|
47.6%
79/166 • Number of events 137 • 14 Days
|
|
Gastrointestinal disorders
Flatulence
|
22.2%
34/153 • Number of events 41 • 14 Days
|
25.3%
42/166 • Number of events 47 • 14 Days
|
|
Gastrointestinal disorders
Constipation
|
13.7%
21/153 • Number of events 21 • 14 Days
|
7.8%
13/166 • Number of events 13 • 14 Days
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
12/153 • Number of events 12 • 14 Days
|
9.0%
15/166 • Number of events 18 • 14 Days
|
|
General disorders
Pyrexia
|
5.9%
9/153 • Number of events 9 • 14 Days
|
3.6%
6/166 • Number of events 10 • 14 Days
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
21.6%
33/153 • Number of events 51 • 14 Days
|
19.3%
32/166 • Number of events 50 • 14 Days
|
|
Investigations
Body temperature increased
|
4.6%
7/153 • Number of events 10 • 14 Days
|
4.2%
7/166 • Number of events 11 • 14 Days
|
|
Nervous system disorders
Headache
|
7.2%
11/153 • Number of events 14 • 14 Days
|
6.0%
10/166 • Number of events 11 • 14 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place