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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• • Male aged 16 years or less or female aged 14 years or less

• Open physis on radiographs

• Fracture undergoing closed treatment or operative treatment or patient undergoing elective osteotomy

Exclusion Criteria:

• • Regular use of NSAIDs

• Allergy to NSAIDs

• Inability to take breakthrough medications due side effects or allergy

• Systemic illness

• Renal impairment

• Liver disease

• Polytrauma

• Uncontrolled diabetes

• Regular use of corticosteroids

• History of any skeletal dysplasia

• History of neuromuscular disorder

• History of bleeding disorder

• History of liver disorder

• Pathologic fracture

• Closed physes

• Male greater than 16 years old

• Female greater than 14 years old

• Pregnant or possibly pregnant females based on report and last menstrual period