Pain control options after elbow surgery in children
A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture
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 |
| Enrollment | 90 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03759028 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-12 with closed Gartland type II or III supracondylar humerus fractures requiring surgical fixation.
Not a fit: Patients with open fractures, those requiring open reduction, or those with significant concomitant injuries will not benefit from this study.
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 performed: Other studies have shown promising results in using non-narcotic pain management strategies in pediatric populations, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.