Trial Outcomes & Findings for NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures (NCT NCT04905563)
NCT ID: NCT04905563
Last Updated: 2024-03-08
Results Overview
Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
24 hours (duration of post-operative stay)
Results posted on
2024-03-08
Participant Flow
Participant milestones
| Measure |
Control
Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
Acetaminophen-Hydrocodone: Narcotic
|
Treatment
Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.
Acetaminophen and Ibuprofen: Non-narcotic
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Control
Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
Acetaminophen-Hydrocodone: Narcotic
|
Treatment
Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.
Acetaminophen and Ibuprofen: Non-narcotic
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Standard of care orders entered by resident
|
1
|
0
|
|
Overall Study
Patient discharged from PACU. No study meds adinistered
|
0
|
1
|
Baseline Characteristics
NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures
Baseline characteristics by cohort
| Measure |
Control
n=13 Participants
Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
Acetaminophen-Hydrocodone: Narcotic
|
Treatment
n=13 Participants
Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.
Acetaminophen and Ibuprofen: Non-narcotic
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.8 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
6.6 Years
STANDARD_DEVIATION 0.92 • n=7 Participants
|
6.7 Years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours (duration of post-operative stay)Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).
Outcome measures
| Measure |
Control
n=13 Participants
Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
Acetaminophen-Hydrocodone: Narcotic
|
Treatment
n=13 Participants
Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.
Acetaminophen and Ibuprofen: Non-narcotic
|
|---|---|---|
|
Pain Scores
|
0.95 score on a scale
Standard Deviation 1.35
|
0.97 score on a scale
Standard Deviation 1.53
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place