Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Acetaminophen; Codeine; Ibuprofen

Criteria

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