Comparison of the efficacy of paracetamol versus paracetamol, codeine and promethazine (Painstop(R)) for premedication and analgesia for myringotomy in children

This prospective double-blinded study compared the analgesic effectiveness and incidence of complications of a compound preparation Painstop(R) (Paedpharm Pty Ltd) containing paracetamol 12 mg, codeine 0.5 mg and promethazine 0.65 mg per 1.0 ml dosage 1.0 ml/kg, with paracetamol 20 mg/kg. Ninety-five children aged 1 to 12 years, ASA 1-2, scheduled for myringotomy and drain tube insertion as a day procedure were randomized to receive Painstop or paracetamol 30 to 60 minutes prior to surgery. Preoperative drowsiness and complications on induction and postoperative sedation, pain and times to achieve goals were recorded. The groups were comparable for age, gender weight, anaesthetic technique and duration of surgery. Times to eye opening (P=0.05) and first oral intake (P=0.006) were significantly longer in the Painstop group. There was, however, no difference in times to discharge. Late sedation was more common in the Painstop group (P=0.03). Pain scores were low and similar in both groups and the need for additional analgesia was uncommon.