Acute Pediatric Fracture Analgesia Study

Not Applicable

Completed

• Conditions: Fracture
• Interventions: Drug: ibuprofen; Drug: acetamin w codeine

• Registration Number: NCT00520442
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-24
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-06
• Last Update Posted: 2008-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Children ages 4-18 years of age with an uncomplicated forearm fracture that is evaluated within 12 hours of injury and requires only splinting

Exclusion Criteria

• A history of a bleeding disorder, uncontrolled chronic medical disease, regularly use of or allergy to acetaminophen, ibuprofen, or codeine or developmental delay

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	ibuprofen	-
acetamin w codeine	acetamin w codeine	-

Primary Outcome Measures

Name	Time	Method
Change to rescue medication	First 72 hours after ED discharge

Secondary Outcome Measures

Name	Time	Method
Pain score	First 72 hours after ED discharge
Functional outcomes: eat, sleep, play, school	First 72 hours after ED discharge

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States