Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT00474721
• Lead Sponsor: University of California, San Diego

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.

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.

Study Timeline

• Study Start: 2002-11
• Study Completion: 2004-02
• Status Verified: 2007-05
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Last Update Submitted: 2007-05-16
• Study First Posted: 2007-05-17
• Last Update Posted: 2007-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in color analog scale pain score	40 minutes

Secondary Outcome Measures

Name	Time	Method
adverse reaction	during ED stay
need for rescue medication	during ED stay
Change in pain score	20 and 60 minutes

Trial Locations

Locations (1)

Rady Children's Hospital; 🇺🇸 San Diego, California, United States