Supracondylar Post-Operative Pain Study

NCT03759028 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB# 18-001158
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Faces Pain Scale-Revised (FPSR)

  Self reported measure of pain on scale 0-10. 0 = no pain; 10 = worst pain imaginable

  24 to 48 hours post-operatively

Secondary Outcomes (1)

• Total Quality Pain Management Instrument

  1 week at first post-operative follow-up

Other Outcomes (1)

• Pain medication logs

  Immediately after surgery at time of randomization until the patient returns for 1st post-operative visit, 7-10 days post-operatively, assessed up to 10 days.

Study Arms (2)

Ibuprofen

EXPERIMENTAL

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).

Drug: Ibuprofen; Drug: Acetaminophen

Oxycodone

ACTIVE COMPARATOR

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).

Drug: Oxycodone; Drug: Acetaminophen

Interventions

Ibuprofen DRUG

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

Also known as: Advil, Motrin

Ibuprofen

Oxycodone DRUG

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

Also known as: roxicodone

Oxycodone

Acetaminophen DRUG

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

Also known as: Tylenol, Paracetamol

Ibuprofen; Oxycodone

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Closed supracondylar humerus fracture
• Isolated supracondylar humerus fracture
• Type II and III supracondylar humerus fracture
• Fractures treated with closed reduction percutaneous pinning

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Orthopaedic Institute for Children

Los Angeles, California, 90007, United States

RECRUITING

MeSH Terms

Conditions

Elbow Fractures

Interventions

Ibuprofen; Oxycodone; Acetaminophen

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Mauricio Silva, MD

  UCLA/OIC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnathan You, BS

CONTACT

2137421074; JohnathanYou@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization envelopes used to allocate treatment groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double blinded, randomized trial

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 29, 2018
• Study Start: February 26, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)