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Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
Sponsor: Major Extremity Trauma Research Consortium
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
Conditions
Interventions
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