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Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00474721
Study type Interventional
Source University of California, San Diego
Contact
Status Completed
Phase N/A
Start date November 2002
Completion date February 2004
View Details
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