Objectives: This study compared the analgesic effectiveness of acetaminophen-codeine with that of ibuprofen for children with acute traumatic extremity pain, with the hypothesis that the two medications would demonstrate equivalent reduction in pain scores in an emergency department (ED) setting.
Methods: This was a randomized, double-blinded equivalence trial. Pediatric ED patients 5 to 17 years of age with acute traumatic extremity pain received acetaminophen-codeine (1 mg/kg as codeine, maximum 60 mg) or ibuprofen (10 mg/kg, maximum 400 mg). The patients provided Color Analog Scale (CAS) 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 to a previously described minimal clinically significant change in pain score of 2 cm. The difference was defined as (change in ibuprofen CAS score from baseline) - (change in acetaminophen-codeine CAS score from baseline); negative values thus favor the ibuprofen group. Additional outcomes included need for rescue medication and adverse effects.
Results: The 32 acetaminophen-codeine and the 34 ibuprofen recipients in our convenience sample had indistinguishable pain scores at baseline. The intergroup differences in pain score change at 20 minutes (-0.6, 95% confidence interval [CI] = -1.5 to 0.3), 40 minutes (-0.4, 95% CI = -1.4 to 0.6), and 60 minutes (0.2, 95% CI = -0.8 to 1.2) were all less than 2 cm. Adverse effects were minimal: vomiting (one patient after acetaminophen-codeine), nausea (one patient after ibuprofen), and pruritus (one after acetaminophen-codeine). The three patients in each group who received rescue medications all had radiographically demonstrated fractures or dislocations.
Conclusions: This study found similar performance of acetaminophen-codeine and ibuprofen in analgesic effectiveness among ED patients aged 5-17 years with acute traumatic extremity pain. Both drugs provided measurable analgesia. Patients tolerated them well, with few treatment failures and minimal adverse effects.