Status:
TERMINATED
NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures
Lead Sponsor:
Le Bonheur Children's Hospital
Collaborating Sponsors:
The Campbell Foundation
Conditions:
Supracondylar Humerus Fracture
Eligibility:
All Genders
4-13 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as c...
Detailed Description
For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprof...
Eligibility Criteria
Inclusion
- isolated supracondylar humerus fracture
- undergoing closed reduction with percutaneous pinning (CRPP)
Exclusion
- Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone
- Liver or renal disease
- history of bleeding disorder
- medical diagnosis of juvenile arthritis
- on chronic NSAIDs or Opioids PRIOR to the procedure
- medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma)
- vascular compromise and/or compartment syndrome upon admission
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04905563
Start Date
June 7 2021
End Date
January 5 2024
Last Update
March 8 2024
Active Locations (1)
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1
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38104