drugset / Trial / NCT07006675
Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
Phase 3
Recruiting
1000 enrolled
Major Extremity Trauma Research Consortium
United States Department of Defense · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-05-26
- Primary completion
- 2026-12
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ibuprofen | Small molecule | 600 mg | Oral |
Indications
No indication recorded.