Acute Pediatric Fracture Analgesia Study

Fracture Clinical Trial

Official title:

Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520442
• Other study ID #: Fracture Pain
• Status: Completed
• Phase: N/A
• First received: August 22, 2007
• Last updated: March 6, 2008
• Start date: September 2003
• Est. completion date: September 2007

Study information

• Verified date: March 2008
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone

Intervention

Drug:
• ibuprofen

• acetamin w codeine

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change to rescue medication		First 72 hours after ED discharge
Secondary	Pain score		First 72 hours after ED discharge
Secondary	Functional outcomes: eat, sleep, play, school		First 72 hours after ED discharge