drugset
drugset / Trial / NCT05000281

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

NCT05000281 ↗

Phase 3 Unknown 1000 enrolled Major Extremity Trauma Research Consortium
RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2021-09-14
Primary completion
2024-09
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule 600 mg —

Indications

No indication recorded.