Acute Pediatric Fracture Analgesia Study
Information source: Medical College of Wisconsin
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fracture
Intervention: ibuprofen (Drug); acetamin w codeine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Medical College of Wisconsin Official(s) and/or principal investigator(s):
Amy L Drendel, DO, Principal Investigator, Affiliation: Medical College of Wisconsin
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.
Clinical Details
Official title: Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change to rescue medication
Secondary outcome: Pain scoreFunctional outcomes: eat, sleep, play, school
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.
Eligibility
Minimum age: 4 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53201, United States
Additional Information
Starting date: September 2003
Ending date: September 2007
Last updated: March 6, 2008
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