Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at baseline and at 20, 40, and 60 minutes after medication administration. The primary outcome measured was the difference in changes in pain score at 40 minutes, compared against a previously described minimal clinically significant change in pain score of 2 cm. Additional outcomes included need for rescue medication and adverse effects.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ibuprofen

Intervention Type DRUG

acetaminophen with codeine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 5 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

Exclusion Criteria

* 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

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Janet H Friday

Role: PRINCIPAL_INVESTIGATOR

UCSD, Dept of Pediatrics and Rady Children's Hospital

Locations

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Rady Children's Hospital

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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RCHSD10926

Identifier Type: -

Identifier Source: org_study_id