Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT03759028

Conditions

Supracondylar Humerus Fracture

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Interventions

Ibuprofen

Oxycodone

Acetaminophen

Study Details

Brief 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.

Conditions

Supracondylar Humerus Fracture

Study ID

NCT03759028

Start date

Feb 26, 2019

Status verified date

Apr, 2026

Completion date

Dec 20, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ibuprofen

This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed ibuprofen for breakthrough pain (liquid oral medication, 10mg/kg/dose every 8 hours as needed, max dose 40mg/kg/day).

active comparator: Oxycodone

This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed oxycodone for breakthrough pain (liquid oral medication, 0.1mg/kg/dose every 6 hours as needed).

Interventions

Ibuprofen

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

Oxycodone

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

Acetaminophen

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

Primary outcome measure

  • Faces Pain Scale-Revised (FPSR) [ Time Frame: 24 to 48 hours post-operatively ]

Central Contacts and Locations

Central contacts

Lindsey Han, BA

2137421074LLHan@mednet.ucla.edu

Locations

Orthopaedic Institute for Children

Recruiting

Los Angeles, California, United States, 90007

Contacts

Jared Alswang

2137426537JAlswang@mednet.ucla.edu

Christina K Sun

2137421057CKSun@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • closed reduction percutaneous pinning
  • post-operative pain control
  • opioid
  • pediatric
  • elbow fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-04-07.