Acute Pediatric Fracture Analgesia Study | NCT00520442

Studies
Acute Pediatric Fracture Analgesia Study

NCT00520442

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Mar 7, 2008Estimated

Enrollment

335Estimated

Phase

Not Applicable

Conditions

Fracture

Interventions

ibuprofen
acetamin w codeine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Aug 22, 2007

First Submission Date that Met QC Criteria

Aug 22, 2007

First Posted Date

Aug 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2008

Last Update Posted Date

Mar 7, 2008Estimated

Name	Class
Children's Hospital and Health System Foundation, Wisconsin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

335Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ibuprofen	Experimental		Drug: ibuprofen
acetamin w codeine	Active Comparator		Drug: acetamin w codeine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ibuprofen	Drug		Ibuprofen	motrin advil
acetamin w codeine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change to rescue medication		First 72 hours after ED discharge

Secondary Outcomes

Measure	Description	Time Frame
Pain score		First 72 hours after ED discharge
Functional outcomes: eat, sleep, play, school		First 72 hours after ED discharge

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy L Drendel, DO	Medical College of Wisconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Wisconsin		Milwaukee	Wisconsin	53201	United States

ID	Term
D050723	Fractures, Bone

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D007052	Ibuprofen
D000082	Acetaminophen
D003061	Codeine
D014284	Triiodothyronine

Ancestor Terms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided