Pain
Conditions
Keywords
child, pain, analgesics
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.
Interventions
DRUGibuprofen
DRUGacetaminophen with codeine
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in color analog scale pain score | 40 minutes |
Secondary
| Measure | Time frame |
|---|---|
| adverse reaction | during ED stay |
| need for rescue medication | during ED stay |
| Change in pain score | 20 and 60 minutes |
Countries
United States
Outcome results
None listed