A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture

What this Trial Is About

Researchers are evaluating post-operative pain control options for children aged 5 to 12 with closed supracondylar humerus fractures who undergo closed reduction and percutaneous pinning surgery. The study compares the pain relief effects of acetaminophen combined with either ibuprofen or oxycodone. This randomized, double-blinded trial aims to assess if using acetaminophen and ibuprofen can reduce opioid prescriptions while maintaining effective pain control and parent/patient satisfaction. Participants will receive acetaminophen as the primary pain medication, given as a liquid oral dose every 6 hours as needed, with either ibuprofen or oxycodone provided for breakthrough pain. Each patient gets 18 doses (3 days) of acetaminophen and the assigned study medication. The surgeries are performed under general anesthesia without regional or local anesthetics, followed by immobilization in a long arm splint. Patients are randomized before discharge to receive one of the two medication combinations, with parents and investigators blinded to which breakthrough pain medication is given. Parents will monitor and record their child's pain levels using the Faces Pain Scale-Revised at 24 and 48 hours post-surgery and complete questionnaires on satisfaction and medication side effects. A medication log will track dosage and any adverse effects. The study involves two visits: recruitment at surgery and a first post-operative follow-up about one week later. Researchers will evaluate pain control effectiveness and parent satisfaction, aiming to improve post-operative care while potentially reducing opioid use in children.

Supracondylar Post-Operative Pain Study