Overview

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures

Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. 1,000 patients with tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management and no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).
Phase:
Phase 3
Details
Lead Sponsor:
Major Extremity Trauma Research Consortium
Treatments:
Ibuprofen