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Acute Pediatric Fracture Analgesia Study

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Completed
CT.gov ID
NCT00520442
Collaborator
Children's Hospital and Health System Foundation, Wisconsin (Other)
335
Enrollment
1
Location
2
Arms
48
Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
335 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures
Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Sep 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ibuprofen

Drug: ibuprofen
Other Names:
  • motrin
  • advil

    		•
    Active Comparator: acetamin w codeine

    Drug: acetamin w codeine
    Other Names:
  • tylenol with codeine, T3

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change to rescue medication [First 72 hours after ED discharge]

    Secondary Outcome Measures

    1. Pain score [First 72 hours after ED discharge]

    2. Functional outcomes: eat, sleep, play, school [First 72 hours after ED discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53201

    Sponsors and Collaborators

    • Medical College of Wisconsin
    • Children's Hospital and Health System Foundation, Wisconsin

    Investigators

    • Principal Investigator: Amy L Drendel, DO, Medical College of Wisconsin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00520442
    Other Study ID Numbers:
    • Fracture Pain
    First Posted:
    Aug 24, 2007
    Last Update Posted:
    Mar 7, 2008
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    fracture
    Additional relevant MeSH terms:
    Fractures, Bone
    Ibuprofen
    Codeine

    Study Results

    No Results Posted as of Mar 7, 2008