Effect of nonsteroidal anti-inflammatory drugs on union, opioid utilization, and pain management for tibial fractures (NSAID Trial): a pragmatic randomized clinical trial protocol.

Abstract

The orthopaedic community has largely avoided the use of nonsteroidal anti-inflammatory drugs (NSAIDs) for the management of pain after fractures based on a combination of animal and clinical data, which suggest their association with impeded fracture healing. Given the significant deleterious effects of opiate analgesics, the use of NSAIDs for pain management in fracture care would be advantageous if potential concerns related to bone healing could be resolved. This study is designed to determine whether planned use of scheduled NSAIDs after fracture leads to a difference in fracture union rates, which in turn provides evidence regarding whether prohibition of NSAID use is justified. This was a prospective, two-arm, pragmatic, randomized-controlled multicenter Phase III noninferiority trial. The study was conducted at 14 Level I trauma centers across the United States and Canada. Patients aged 18 to 80 years with open (Gustilo Type I, II, or IIIA) or closed tibia fractures treated with intramedullary nailing were included. Patients received 600 milligrams of ibuprofen, 3 times daily, for up to 6 weeks. Secondary surgery to achieve union within 12 months of definitive fixation was recorded.