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

RecruitingPhase 3Ages 18 Years - 80 YearsAllMajor Extremity Trauma Research Consortium
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail. 2. Patients 18-80 years old inclusive. 3. Patients able to be followed at a METRC facility for at least 12 months following injury Exclusion Criteria: 1. Patient unable to provide informed consent 2. Patients who are current - intravenous drug user. 3. Patients with a history of allergy to the study drugs. 4. Patients unable to swallow oral medications or without functioning GI tract. 5. Patients with a history of gastrointestinal bleeds or gastric perforation. 6. Patients with a history of stroke or heart attack. 7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg. 8. Patients with any bleeding disorders. 9. Patients with severe renal failure \[GFR:\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose \[see section 8.6 for defined modified dose\]. 10. Patients undergoing daily treatment with systemic glucocorticoids before surgery. 11. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations. 12. Patients with a GCS \<15 at discharge. 13. Patients with a closed head injury that precludes NSAIDS. 14. Patients who are pregnant or lactating at time of screening 15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.
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What it tests

  • 600 mg Ibuprofen
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Where

14 sites
Eskenazi Hospital
Indianapolis, United States
Indiana University-Methodist
Indianapolis, United States
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, United States
Harvard Medical Center
Cambridge, United States
Hennepin Health
Minneapolis, United States
University of Mississippi
Jackson, United States
The MetroHealth System
Cleveland, United States
Allegheny General Hospital
Pittsburgh, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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