Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries

University of California San Diego

Status

Completed

Conditions

Pain

Treatments

Drug: acetaminophen with codeine

Drug: ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT00474721

RCHSD10926

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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