Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
Major Extremity Trauma Research Consortium
1,000 participants
May 26, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
- Patients 18-80 years old inclusive.
- Patients able to be followed at a METRC facility for at least 12 months following injury
Exclusion Criteria15
- Patient unable to provide informed consent
- Patients who are current - intravenous drug user.
- Patients with a history of allergy to the study drugs.
- Patients unable to swallow oral medications or without functioning GI tract.
- Patients with a history of gastrointestinal bleeds or gastric perforation.
- Patients with a history of stroke or heart attack.
- Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
- Patients with any bleeding disorders.
- Patients with severe renal failure \[GFR:\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose \[see section 8.6 for defined modified dose\].
- Patients undergoing daily treatment with systemic glucocorticoids before surgery.
- 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.
- Patients with a GCS \<15 at discharge.
- Patients with a closed head injury that precludes NSAIDS.
- Patients who are pregnant or lactating at time of screening
- Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.
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Interventions
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)
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NCT07006675