drugset / Trial / NCT02076321

The Effect of NSAID Use in the Acute Phase of Skeletally Immature Bone Healing: A Prospective Study

NCT02076321

Phase 4 Completed 102 enrolled University of Missouri-Columbia
RandomizedParallel-groupOpen-labelTreatment

Summary

Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications for providing pain control in children with fractures or those who have surgery to correct bony deformity requiring the bone to be cut (osteotomy) and realigned. There is some data to suggest that these types of medications can adversely affect bone healing in adult patients with broken bones or those having spine fusion surgery. There is little data with regard to how these medications effect bone healing in children. With this project, the investigators' goal is to determine if NSAIDs delay or otherwise adversely effect bone healing and to demonstrate that these medications adequately control pain in children with broken bones or those who have had an osteotomy.

Timeline

Start
2014-01
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 10 mg/kg
Subject Acetaminophen Small molecule 15 mg/kg
Subject Ibuprofen Small molecule 4 mg/kg
Subject Ibuprofen Small molecule 10 mg/kg

Indications

No indication recorded.