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