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...
Date First Received: August 22, 2007
Last Updated: March 6, 2008
Verified by: Medical College of Wisconsin, March 2008
Clinical Trial Phase: N/A | Start Date: September 2003
Overall Status: Completed
Estimated Enrollment: 335
Brief Summary
Official Title: “Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: September 2007
Detailed Clinical Trial 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.Intervention(s) in this Clinical Trial
- Drug: ibuprofen
- Drug: acetamin w codeine
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Ibuprofen
- Active Comparator: acetamin w codeine
Outcome Measures for this Clinical Trial
Primary Measures
- Change to rescue medication
- Time Frame: First 72 hours after ED discharge
- Time Frame: First 72 hours after ED discharge
Secondary Measures
- Pain score
- Time Frame: First 72 hours after ED discharge
- Time Frame: First 72 hours after ED discharge
- Functional outcomes: eat, sleep, play, school
- Time Frame: First 72 hours after ED discharge
- Time Frame: First 72 hours after ED discharge
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 4 Years
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Medical College of Wisconsin
Overall Clinical Trial Officials and Contacts
Amy L Drendel, DO Principal Investigator Medical College of Wisconsin
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00520442
Study ID Number: Fracture Pain
ClinicalTrials.gov Identifier: NCT00520442
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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