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Analgesic

Pain Management for Broken Arm

Phase 4

Waitlist Available

Led By Jaclyn Hill, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from discharge until pain medication is no longer required (assessed up to 3 weeks)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial studies if over-the-counter pain meds can provide adequate relief to children after elbow surgery, reducing opioid prescriptions and unnecessary opioids.

Who is the study for?

This trial is for children with specific elbow fractures (Gartland type II or III) treated surgically, who can return to Texas Children's Hospital for follow-up. Participants must speak English or Spanish. It excludes those with open wounds, multiple injuries, nerve/blood vessel damage, intellectual delays affecting pain reporting, bone healing disorders like osteogenesis imperfecta, allergies to the medications used in the study, severe kidney disease, prior chronic NSAID or opioid use before injury.

What is being tested?

The study compares two pain management strategies after elbow surgery in children: one using over-the-counter drugs ibuprofen and acetaminophen versus another combining ibuprofen with an opioid (hydrocodone/acetaminophen). The goal is to see if non-opioid meds are as effective as opioids for post-surgery pain relief which could reduce early exposure to opioids and their circulation.

What are the potential side effects?

Possible side effects include stomach upset and bleeding risks from ibuprofen; liver damage from excessive acetaminophen; drowsiness, constipation, nausea from hydrocodone/acetaminophen. Long-term opioid use may lead to dependency issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from discharge until pain medication is no longer required (assessed up to 3 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from discharge until pain medication is no longer required (assessed up to 3 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from discharge until pain medication is no longer required (assessed up to 3 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Daily Pain Scores on the FACES Scale

Secondary study objectives

Number of Days Pain Medication Required

Number of Pain Medication Doses Required per Day

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: Non-Opioid Pain ManagementExperimental Treatment2 Interventions

Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.

Group II: Opioid Pain ManagementActive Control2 Interventions

Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibuprofen

2013

Completed Phase 4

~5800

Acetaminophen

2017

Completed Phase 4

~2030