NCT00520442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 7, 2008

Status Verified

March 1, 2008

Enrollment Period

4 years

First QC Date

August 22, 2007

Last Update Submit

March 6, 2008

Conditions

Fracture

Keywords

fracture

Outcome Measures

Primary Outcomes (1)

  • Change to rescue medication

    First 72 hours after ED discharge

Secondary Outcomes (2)

  • Pain score

    First 72 hours after ED discharge

  • Functional outcomes: eat, sleep, play, school

    First 72 hours after ED discharge

Study Arms (2)

Ibuprofen

EXPERIMENTAL
Drug: ibuprofen

acetamin w codeine

ACTIVE COMPARATOR
Drug: acetamin w codeine

Interventions

ibuprofenDRUG
Also known as: motrin, advil
Ibuprofen
acetamin w codeineDRUG
Also known as: tylenol with codeine, T3
acetamin w codeine

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children ages 4-18 years of age with an uncomplicated forearm fracture that is evaluated within 12 hours of injury and requires only splinting

You may not qualify if:

  • A history of a bleeding disorder, uncontrolled chronic medical disease, regularly use of or allergy to acetaminophen, ibuprofen, or codeine or developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

IbuprofenAcetaminophenCodeineTriiodothyronine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Amy L Drendel, DO

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 24, 2007

Study Start

September 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

March 7, 2008

Record last verified: 2008-03

Locations

US(1)