Status:
RECRUITING
Supracondylar Post-Operative Pain Study
Lead Sponsor:
University of California, Los Angeles
Conditions:
Supracondylar Humerus Fracture
Eligibility:
All Genders
5-12 years
Phase:
PHASE4
Brief Summary
The purpose of this study to investigate post-operative pain control in pediatric patients with closed supracondylar humerus fracture who undergo closed reduction and percutaneous pinning. Currently, ...
Detailed Description
This is a double-blinded, randomized controlled trial comparing the analgesic efficacy between acetaminophen and ibuprofen versus acetaminophen and oxycodone for postoperative pain control in patients...
Eligibility Criteria
Inclusion
- Closed supracondylar humerus fracture
- Isolated supracondylar humerus fracture
- Type II and III supracondylar humerus fracture
- Fractures treated with closed reduction percutaneous pinning
Exclusion
- Fractures with concomitant vascular injury
- Fractures with concomitant neurologic deficit
- Pathologic fractures
- Fractures with concomitant injuries (multiple trauma)
- Fractures with swelling requiring post-operative hospitalization for monitoring
- Known history of allergies to acetaminophen, ibuprofen or oxycodone
- Patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised
- Patients with intellectual disability that would preclude participation in the visual analog Faces Pain Scale-Revised
- History of suspected child abuse
Key Trial Info
Start Date :
February 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03759028
Start Date
February 26 2019
End Date
December 20 2027
Last Update
April 1 2025
Active Locations (1)
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1
Orthopaedic Institute for Children
Los Angeles, California, United States, 90007