Ketoprofen for add-on pain treatment to paracetamol after strabismus surgery in children.

Objective: To evaluate whether combining ketoprofen, a nonsteroidal anti-inflammatory analgesic, with paracetamol would provide better postoperative analgesia than paracetamol alone in children undergoing strabismus surgery.

Study Design: A prospective, double-blind, randomised clinical trial.

Patients And Methods: 56 generally healthy children, aged 3-15 years, undergoing strabismus surgery with standardised endotracheal anaesthesia were randomly assigned to receive either ketoprofen 1 mg/kg intravenously or normal saline at induction of anaesthesia and a second dose 3h later. All children received paracetamol 24 mg/kg solution orally 60 min before surgery and fentanyl 2 mug/kg intravenously during surgery. For rescue analgesia during the first 6h children in pain (pain score >3 on an 11-point scale: 0 = no pain, 10 = worst possible pain) received fentanyl 1 mug/kg intravenously. Any episodes of vomiting and all other adverse events were recorded for the first 24h.

Results: 21 of 27 children in the ketoprofen-paracetamol group (78%) and 23 of 29 in the paracetamol group (79%) received fentanyl for rescue analgesia. The mean (SD) number of fentanyl doses during the first 6h was 1.2 (0.9) in the ketoprofen-paracetamol group and 1.7 (1.1) doses in the paracetamol group (mean difference 0.5 doses; 95% CI for difference: -0.1, 1.3; p = 0.11). Eight (30%) vomited in the ketoprofen-paracetamol group and 14 in the paracetamol group (48%) [difference 19%; 95% CI -6, 44; p = 0.15). No serious adverse events occurred.

Conclusion: Neither paracetamol nor ketoprofen-paracetamol provided sufficient analgesia for children after strabismus surgery because most needed rescue analgesia.