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Pain Management Medications for Post-Operative Pain in Broken Arm

Phase 4

Recruiting

Led By Rachel M Thompson, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type II and III supracondylar humerus fracture

Isolated supracondylar humerus fracture

Must not have

Fractures with concomitant injuries (multiple trauma)

Fractures with concomitant vascular injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is investigating whether using ibuprofen and acetaminophen to control pain after surgery is as effective as using acetaminophen and oxycodone, and if it leads to less opioid prescriptions.

Who is the study for?

This trial is for children with certain types of elbow fractures (Type II and III supracondylar humerus fractures) that have been treated surgically. It's not suitable for kids with additional injuries, vascular or nerve damage, swelling needing hospitalization, allergies to the pain meds being tested, or those who can't use the Faces Pain Scale due to developmental delays.

What is being tested?

The study compares two post-surgery pain management approaches in children: one combines acetaminophen (a common over-the-counter pain reliever) with ibuprofen (another OTC anti-inflammatory), while the other pairs acetaminophen with oxycodone (a stronger prescription opioid). The effectiveness will be measured by how well they control pain and parent/patient satisfaction.

What are the potential side effects?

Acetaminophen may cause liver issues if used too much. Ibuprofen can lead to stomach upset or bleeding. Oxycodone is a strong medication that might cause constipation, nausea, drowsiness, breathing problems and has a risk of dependency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a type II or III break in the bone above my elbow.

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I have a fracture in the bone above my elbow.

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I have a broken bone above my elbow that hasn't pierced the skin.

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I had a fracture fixed without surgery, using pins.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have fractures and other injuries from a major accident.

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I have a broken bone with a related blood vessel injury.

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I have a broken bone with nerve damage.

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I have had fractures due to my disease.

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I had a fracture that needed surgery and stayed in the hospital for monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Faces Pain Scale-Revised (FPSR)

Secondary study objectives

Total Quality Pain Management Instrument

Other study objectives

Pain medication logs

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IbuprofenExperimental Treatment2 Interventions

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).

Group II: OxycodoneActive Control2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

Ibuprofen

2013

Completed Phase 4

~5800