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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Daily Pain Scores on the FACES Scale

Secondary outcome measures

Number of Days Pain Medication Required

Number of Pain Medication Doses Required per Day

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,852 Total Patients Enrolled

1 Trials studying Supracondylar Humerus Fractures

Jaclyn Hill, MDPrincipal InvestigatorBaylor College of Medicine

Scott Rosenfeld, MDPrincipal InvestigatorBaylor College of Medicine

Media Library

Acetaminophen (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05640674 — Phase 4

Supracondylar Humerus Fractures Research Study Groups: Opioid Pain Management, Non-Opioid Pain Management

Supracondylar Humerus Fractures Clinical Trial 2023: Acetaminophen Highlights & Side Effects. Trial Name: NCT05640674 — Phase 4

Acetaminophen (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05640674 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals aged under 75 years participate in this research?

"To be eligible for participation in this study, patients must fall between 3 and 12 years of age."

Answered by AI

Has the FDA sanctioned Non-Opioid Pain Management treatments?

"There is a plethora of evidence validating the safety of Non-Opioid Pain management, thus it was awarded a score of 3."

Answered by AI

Is participation in this study still attainable?

"According to information available on clinicaltrials.gov, this medical trial is not currently open for recruitment; the date of its initial posting was December 1st 2022 and it has since been amended as recently as November 29th 2022. While there are no spots available in this study at present, 358 other trials are actively seeking participants now."

Answered by AI

What are the eligibility criteria for participation in this clinical experiment?

"This medical trial intends to recruit 100 patients, aged 3-12 years old that have fractured their humerus. Those eligible must meet the following criteria: Closed supracondylar humerus fracture (Gartland type II or III), Fractures treated with closed reduction and percutaneous pinning (CRPP), Patients expected to follow up at Texas Children's Hospital, Ability of patient/guardian to communicate in either English or Spanish."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Scott Rosenfeld 2023. "Post-operative Pain Management in Children With Supracondylar Humerus Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05640674.