Analgesic efficacy of paracetamol in children using tonsillectomy as a pain model.

The analgesic efficacy of paracetamol was assessed in a prospective, randomized, double-blinded study of 100 children undergoing tonsillectomy with or without adenoidectomy. Fifty children were given paracetamol elixir 40 mg/kg 40 minutes preoperatively (Group A); the remaining 50 children were given an oral placebo 40 minutes preoperatively and paracetamol suppositories 40 mg/kg after induction of anaesthesia (Group B). Paracetamol was the only analgesic given and was given either orally or rectally in order to produce high variations in plasma paracetamol concentrations postoperatively. At 30 minutes after the end of surgery a pain score (0-10) was obtained and a venous blood sample was taken for serum paracetamol concentration analysis. Children given paracetamol elixir had a higher mean paracetamol concentration (0.15 [SD 0.06] mmol/l vs 0.05 [SD 0.03] mmol/l, P < 0.001) and a lower median pain score (5 vs 7, P < 0.02) than those who were given suppositories. The use of rescue morphine was higher (10 vs 23, P < 0.001) in the latter group. The incidence of nausea and vomiting was the same in both groups (20%) during the 24 hour postoperative period. Plasma paracetamol concentrations of 0.066-0.132 mmol/l are known to reduce temperature; plasma paracetamol concentrations which provide analgesia are unknown. Children with plasma paracetamol concentrations above 0.07 mmol/l had superior analgesia to those with concentrations below this level (P < 0.05).

RCT Entities:   Population Interventions Outcomes