Abstract
This prospective, randomized, double-blind study compared the analgesic efficacy of oral diclofenac resinate 0.5 mg.kg -1 with paracetamol 15 mg.kg -1 for control of postoperative pain in paediatric patients for outpatient bilateral myringotomy and tube insertion. Paracetamol, the most commonly used oral analgesic for paediatric patients, was compared with a new palatable syrup formulation of diclofenac.
Sixty-three ASA 1 or ASA 2 children aged one year and above were randomly assigned to receive diclofenac (Group A) or paracetamol (Group B). The study drug was given 30 to 60 minutes before induction of anaesthesia. Anaesthesia was induced with either inhalational sevoflurane or intravenous thiopentone. All subjects received intravenous fentanyl 1 μg.kg -1 intraoperatively. Postoperative pain was assessed by a blinded observer using the CHEOPS score on eye-opening, and then at 10, 30 and 60 minutes. Children with a CHEOPS score >7 received further fentanyl 1 μg.kg -1 . The number of cases requiring this “rescue” analgesia was recorded.
Both groups were comparable in demographics, induction technique, duration of anaesthesia and time between premedication and induction of anaesthesia. Overall, CHEOPS scores were low for both groups at all times and did not differ between the groups at any time. Twenty per cent of the diclofenac group and 27% of the paracetamol group required rescue analgesia (not statistically significant). The efficacy of diclofenac 0.5 mg.kg –1 and paracetamol 15 mg.kg –1 as oral analgesic premedication for BMT was comparable in children receiving an anaesthetic which included intraoperative administration of fentanyl 1 μg.kg –1 .