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Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: ibuprofen (Drug); acetaminophen with codeine (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
Janet H Friday, Principal Investigator, Affiliation: UCSD, Dept of Pediatrics and Rady Children's Hospital


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.

Clinical Details

Official title: A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change in color analog scale pain score

Secondary outcome:

adverse reaction

need for rescue medication

Change in pain score

Detailed description: 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.


Minimum age: 5 Years. Maximum age: 18 Years. Gender(s): Both.


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;


- Use of central nervous system depressants such as ethanol, benzodiazepines,

barbiturates, antidepressants, or recreational drugs

Locations and Contacts

Rady Children's Hospital, San Diego, California 92123, United States
Additional Information

Starting date: November 2002
Last updated: May 16, 2007

Page last updated: August 23, 2015

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