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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
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture focused on measuring fracture

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

First Posted
August 22, 2007
Last Updated
March 6, 2008
Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
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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

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Acute Pediatric Fracture Analgesia Study

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