Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

Completed · Not applicable

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00474721

Run by

University of California, San Diego

People needed

68

Starts

2002-11-01

Expected to finish

2004-02-01

Last updated by the study team

2007-05-17

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rady Children's Hospital — San Diego, California, United States

Full record on ClinicalTrials.gov

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