Propacetamol versus placebo for management of acute postoperative pain after elective tonsillectomy in children

The analgesic efficacy and safety of propacetamol, an injectabie prodrug of acetaminophen, was assessed versus placebo after elective tonsillectomy operation in children. Using a double-blind, randomized parallel group design, 70 children aged 6-12 years were included to evaluate the effect of a single iv infusion of 40 mg/kg propacetamol versus a single infusion of 100 ml normal saline [placebo] given at the recovery room. Analgesic efficacy was assessed on pain scores rated on a four-points verbal scale, a five-points visual scale [faces] and a four-points pain relief verbal scale; before administration [TO] and 0.25, 0.5, 1, 2, 3, 4, 5 and 6 hours after the infusion. The global efficacy was rated on a five-point scale at the end of the study. Rescue medication was allowed freely and the time for re-medication as well as the occurrence of any side effects was recorded. Propacetamol was statistically superior to placebo on all assessment criteria. The global final efficacy evaluation demonstrated 12 patients in the propacetamol group with good and very good scores compared to only one patient in the placebo group. Rescue medication was used in 40% of patients in the propacetamo! group versus 83% in the placebo group. No serious side effects were recorded in both groups and pain at the infusion arm was noticed in 4 patients with propacetamol and 2 patients in the placebo group [P> 0.05]. We concluded that, although propacetamol 40 mg/kg infusion may provide greater pain relief than placebo in children after tonsillectomy operation without any significant adverse effects, it is better to be used as a complementary drug to other analgesics in the treatment of moderate to severe postoperative pain