Pain control options after elbow surgery in children
Official title: A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture
Run by University of California, Los Angeles · NCT03759028 · Data updated 2026-11-12
This study is testing two different ways to manage pain after elbow surgery in kids to see which one works better and uses fewer strong medications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | February 26, 2019 |
| Main results expected | December 1, 2027 |
| Study ends | December 20, 2027 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT03759028 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 5-12 with closed Gartland type II or III supracondylar humerus fractures requiring surgical fixation.
✕Probably not a fit
Patients with open fractures, those requiring open reduction, or those with significant concomitant injuries will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of two pain management strategies for pediatric patients undergoing surgery for closed supracondylar humerus fractures. Participants will be randomly assigned to receive either a combination of acetaminophen and ibuprofen or acetaminophen and oxycodone for post-operative pain relief. The study will assess pain levels using the Wong-Baker FACES scale and gather feedback from parents regarding their satisfaction with pain control. The goal is to determine which pain management approach is more effective while minimizing the use of narcotics.
Why it matters
Potential benefit: If successful, this study could provide safer and more effective pain management options for children recovering from elbow surgery.
How similar studies have gone: Other studies have shown promising results in using non-narcotic pain management strategies in pediatric populations, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Closed supracondylar humerus fracture * Isolated supracondylar humerus fracture * Type II and III supracondylar humerus fracture * Fractures treated with closed reduction percutaneous pinning Exclusion Criteria: * 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
Where it's running
-
Orthopaedic Institute for Children
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Mauricio Silva, MD — Ucla/oic
- Study coordinator: Lindsey Han, BA
- Email: LLHan@mednet.ucla.edu
- Phone: 2137421074
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.