Randomized comparison between the combination of acetaminophen and ibuprofen and each constituent alone for analgesia following tonsillectomy in children.

PURPOSE

Combined acetaminophen and ibuprofen may be more effective than either constituent alone for pain in adults. The combination was compared with the individual constituents for analgesia following tonsillectomy in children.

METHODS

One hundred and fifty-two children (6-14 yr) undergoing tonsillectomy were randomized to receive either combination acetaminophen (48 mg·kg(-1)·day(-1)) and ibuprofen (24 mg·kg(-1)·day(-1)) or the same doses of acetaminophen alone or ibuprofen alone, every six hours for 48 hr. The primary outcome measure was a time-corrected area under the curve (AUCt) calculated from assessments on a 100-mm visual analogue scale (with Wong Baker FACES(®) as anchors). At each assessment the children rated pain while at rest and on swallowing at multiple time points over the study duration. Secondary outcome measures were a global pain rating, requirement for rescue analgesia, sleep disturbance, and frequency of adverse events.

RESULTS

The mean [standard error of the mean (SEM)] AUCt values at rest were; combination 29.6 (1.9), acetaminophen 30.4 (2.0), ibuprofen 34 (1.9). The mean (SEM) AUCt values on swallowing were; combination 39.1 (2.0), acetaminophen 39.9 (2.0), ibuprofen 43.7 (1.9). The mean (95% confidence interval) differences in AUCt values between groups on swallowing were: combination vs acetaminophen -0.9 (-6.2 to 4.5); combination vs ibuprofen -4.6 (-9.9 to 0.67) and at rest were: combination vs acetaminophen -0.81 (-6.11 to 4.48); combination vs ibuprofen -4.37 (-9.62 to 0.88). Differences between groups were not clinically important for the pain scores, similarly for the secondary outcomes.

CONCLUSION

The combination of ibuprofen and acetaminophen was not superior to its individual components in the regimen studied in this pediatric population undergoing tonsillectomy. The study was registered with the Australia New Zealand Clinical Trial Registry (ACTRN12607000005459) on January 4, 2007.