Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
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.
Description
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. We will randomize patients with diaphyseal tibia fractures treated with intramedullary (IM) nail into two treatment arms. The control group will receive standard pain management with no NSAIDs. The treatment intervention group will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN). Our hypothesis is that pain management using up to 6 weeks of NSAIDs will result in improved pain control and lower opio…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 wit…
Interventions
- Drug600 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 HospitalIndianapolis, Indiana
- Indiana University-MethodistIndianapolis, Indiana
- University of Maryland R Adams Cowley Shock Trauma CenterBaltimore, Maryland
- Harvard Medical CenterCambridge, Massachusetts
- Hennepin HealthMinneapolis, Minnesota
- University of MississippiJackson, Mississippi