NCT00520442

Acute Pediatric Fracture Analgesia Study

Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 335 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Accepted

Summary

A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures.

Detailed description

A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures. A random table will be used to generate an assignment of the participants to either ibuprofen or acetaminophen with codeine. Assessment of the child's pain severity, pain medication use, functional limitations and parental satisfaction will allow for identification of a difference in the management of pain in the first 72 hours after a forearm fracture. Descriptive statistics will be used to analyze demographic data.

Conditions

• Fracture

Interventions

Type	Name	Description
DRUG	ibuprofen
DRUG	acetamin w codeine

Timeline

• Start date: 2003-09-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-08-24
• Last updated: 2008-03-07

Locations

1 site across 1 country: United States