Summary

Eligibility
for people ages 5-12 (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by Mauricio Silva, MD (ucla)

Description

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.

Official Title

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

Details

Keywords

Supracondylar Humerus Fracture, closed reduction percutaneous pinning, post-operative pain control, opioid, pediatric, elbow fracture, Bone Fractures, Humeral Fractures, Acetaminophen, Ibuprofen, Oxycodone

Eligibility

Location

  • Orthopaedic Institute for Children accepting new patients
    Los Angeles California 90007 United States

Lead Scientist at University of California Health

  • Mauricio Silva, MD (ucla)
    HS Clinical Professor, Orthopaedic Surgery, Medicine. Authored (or co-authored) 39 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT03759028
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated