NCT00474721

Brief Summary

We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Nov 2002

Typical duration for not_applicable pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
Last Updated

May 17, 2007

Status Verified

May 1, 2007

First QC Date

May 16, 2007

Last Update Submit

May 16, 2007

Conditions

Pain

Keywords

childpainanalgesics

Outcome Measures

Primary Outcomes (1)

  • Change in color analog scale pain score

    40 minutes

Secondary Outcomes (3)

  • adverse reaction

    during ED stay

  • need for rescue medication

    during ED stay

  • Change in pain score

    20 and 60 minutes

Interventions

ibuprofenDRUG
acetaminophen with codeineDRUG

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years of age
  • Spoke English as a primary language
  • Complained of an extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges
  • Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at triage

You may not qualify if:

  • Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen;
  • Administration of any analgesic within 6 hours of presentation;
  • Significant deformity or vascular insufficiency of the extremity requiring immediate treatment as determined by the treating physician;
  • Inability to use the study pain instrument;
  • Any laceration near the suspected injury;
  • Chronic hepatic or renal disease;
  • Pregnancy in the third trimester;
  • Concurrent use of contraindicated medications such as monoamine oxidase inhibitors; or
  • Use of central nervous system depressants such as ethanol, benzodiazepines, barbiturates, antidepressants, or recreational drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ibuprofenacetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Janet H Friday

    UCSD, Dept of Pediatrics and Rady Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 17, 2007

Study Start

November 1, 2002

Study Completion

February 1, 2004

Last Updated

May 17, 2007

Record last verified: 2007-05

Locations

US(1)