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RECRUITING
NCT03759028
PHASE4

Supracondylar Post-Operative Pain Study

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

4 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2019-02-26

Completion Date

2027-12-20

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Ibuprofen

Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.

DRUG

Oxycodone

Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.

DRUG

Acetaminophen

Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.

Locations (1)

Orthopaedic Institute for Children

Los Angeles, California, United States