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NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures

NCT04905563 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-08

Study results available
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Summary

The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.

Conditions

  • Supracondylar Humerus Fracture

Interventions

DRUG

Acetaminophen-Hydrocodone

Narcotic

DRUG

Acetaminophen and Ibuprofen

Non-narcotic

Sponsors & Collaborators

  • The Campbell Foundation

    collaborator OTHER

  • Le Bonheur Children's Hospital

    lead OTHER

Principal Investigators

  • Lindsey Locke, MSN · Le Bonheur Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2024-01-05
Completion
2024-01-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04905563 on ClinicalTrials.gov