Supracondylar Post-Operative Pain Study

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Acetaminophen; Ibuprofen; Oxycodone

Criteria

Inclusion Criteria:

• Closed supracondylar humerus fracture

• Isolated supracondylar humerus fracture

• Type II and III supracondylar humerus fracture

• Fracutres 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