Acute Pediatric Fracture Analgesia Study
Primary Purpose
Fracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ibuprofen
acetamin w codeine
Sponsored by
About this trial
This is an interventional treatment trial for Fracture focused on measuring fracture
Eligibility 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
Sites / Locations
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ibuprofen
acetamin w codeine
Arm Description
Outcomes
Primary Outcome Measures
Change to rescue medication
Secondary Outcome Measures
Pain score
Functional outcomes: eat, sleep, play, school
Full Information
NCT ID
NCT00520442
First Posted
August 22, 2007
Last Updated
March 6, 2008
Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT00520442
Brief Title
Acute Pediatric Fracture Analgesia Study
Official Title
Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture
Keywords
fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
335 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen
Arm Type
Experimental
Arm Title
acetamin w codeine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Other Intervention Name(s)
motrin, advil
Intervention Type
Drug
Intervention Name(s)
acetamin w codeine
Other Intervention Name(s)
tylenol with codeine, T3
Primary Outcome Measure Information:
Title
Change to rescue medication
Time Frame
First 72 hours after ED discharge
Secondary Outcome Measure Information:
Title
Pain score
Time Frame
First 72 hours after ED discharge
Title
Functional outcomes: eat, sleep, play, school
Time Frame
First 72 hours after ED discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy L Drendel, DO
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acute Pediatric Fracture Analgesia Study
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