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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

May 26, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2027

Conditions
Tibial FracturesPain
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.

Trial Locations (14)

15212

RECRUITING

Allegheny General Hospital, Pittsburgh

21201

RECRUITING

University of Maryland R Adams Cowley Shock Trauma Center, Baltimore

22042

RECRUITING

Inova Fairfax Hospital, Falls Church

37203

RECRUITING

Vanderbilt Medical Center, Nashville

39216

RECRUITING

University of Mississippi, Jackson

44109

RECRUITING

The MetroHealth System, Cleveland

46202

RECRUITING

Eskenazi Hospital, Indianapolis

RECRUITING

Indiana University-Methodist, Indianapolis

53705

RECRUITING

University of Wisconsin, Madison

55487

RECRUITING

Hennepin Health, Minneapolis

77030

RECRUITING

University of Texas Health Science Center - Houston, Houston

84108

RECRUITING

University of Utah, Salt Lake City

02138

RECRUITING

Harvard Medical Center, Cambridge

Unknown

RECRUITING

University of Calgary, Foothills Medical Centre, Calgary

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Major Extremity Trauma Research Consortium

OTHER