We regret that Drs. Black and Mackersie clearly have misunderstood the most important result of our study. Our primary goal was to find the effective dose of rectal acetaminophen in children during a day-case surgical setting. When we designed the study groups, we seriously thought to include a small-dose group (10 mg/kg) instead of a placebo group; however, our clinical impression has been that this small dose has no effect on pain. Therefore, a pure placebo group was included in the study. Our anesthesia method with sevoflurane in nitrous oxide and oxygen provides excellent cardiovascular, endocrine, and ventilatory stability for superficial surgery. Pain was assessed and treated postoperatively as effectively as possible. Therefore, we did not see ethical compromises in our study design. The design enabled us to find an effective dose of acetaminophen for 50% of subjects.
Pain treatment of pediatric patients still is often guided by traditions or clinical impressions. Most likely, a balanced pain treatment approach provides better pain control than a single drug. However, to provide effective components for the balanced technique, we have to find the dose–response relation of these single components, and the possible synergism between the components. We recommended that a single dose of rectal acetaminophen should be at least 40 mg/kg and that a daily dose should be limited to that published previously. 1,2We do not recommend increasing the daily dose of acetaminophen, but suggest that a high single dose produces favorable clinical response beyond its expected pharmacokinetic profile. Our young patients would definitely benefit if similar study designs are carried out using other nonsteroidal antiinflammatory drugs and combinations of pain killers in children.