NCT03759028 Supracondylar Post-Operative Pain Study
| NCT ID | NCT03759028 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Los Angeles |
| Condition | Supracondylar Humerus Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2019-02-26 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2019-02-26 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, it is standard of care that patients receive a narcotic prescription for post-operative pain control. All patients will initially be seen in our pediatric urgent care and recruited at the time of surgery. Patients will be randomized to receiving acetaminophen and ibuprofen or acetaminophen and oxycodone. Parents will not be blinded to the acetaminophen but both investigators, parents and the patients will be blinded to the study drug (ibuprofen or oxycodone). Pain level will be assessed using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery to 1st post-op visit). This study is being conducted in hopes of reducing opioid prescription after surgical fixation of uncomplicated supracondylar humerus fractures if our study can show that patient's pain levels post-operatively and parent/patient satisfaction are unchanged or improved in the acetaminophen and ibuprofen arm.
Eligibility 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
Contact & Investigator
Mauricio Silva, MD
PRINCIPAL INVESTIGATOR
UCLA/OIC
Frequently Asked Questions
Who can join the NCT03759028 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Supracondylar Humerus Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03759028 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03759028 currently recruiting?
Yes, NCT03759028 is actively recruiting participants. Contact the research team at LLHan@mednet.ucla.edu for enrollment information.
Where is the NCT03759028 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT03759028 clinical trial?
NCT03759028 is sponsored by University of California, Los Angeles. The principal investigator is Mauricio Silva, MD at UCLA/OIC. The trial plans to enroll 90 participants.