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RECRUITING
NCT07006675
PHASE3

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Sponsor: Major Extremity Trauma Research Consortium

View on ClinicalTrials.gov

Summary

Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2021-05-26

Completion Date

2027-03

Last Updated

2025-06-05

Healthy Volunteers

No

Interventions

DRUG

600 mg Ibuprofen

Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.

Locations (14)

Eskenazi Hospital

Indianapolis, Indiana, United States

Indiana University-Methodist

Indianapolis, Indiana, United States

University of Maryland R Adams Cowley Shock Trauma Center

Baltimore, Maryland, United States

Harvard Medical Center

Cambridge, Massachusetts, United States

Hennepin Health

Minneapolis, Minnesota, United States

University of Mississippi

Jackson, Mississippi, United States

The MetroHealth System

Cleveland, Ohio, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

University of Texas Health Science Center - Houston

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

University of Calgary, Foothills Medical Centre

Calgary, Alberta, Canada