A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture
University of California, Los Angeles
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.
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 following closed reduction and percutaneous pinning for isolated closed supracondylar humerus fractures. Each patient will be evaluated initially at our institution's pediatric urgent care center and placed in a long arm splint with instructions to elevate the affected arm. Patients will not be discharged with any prescriptions for narcotic pain medication and will be instructed to take weight-ba…
Eligibility
- Age range
- 4–12 years
- Sex
- All
- Healthy volunteers
- No
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 tha…
Interventions
- DrugIbuprofen
Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
- DrugOxycodone
Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
- DrugAcetaminophen
Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Location
- Orthopaedic Institute for ChildrenLos Angeles, California