Abstract
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 μg/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 μg/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.
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This study received no external funding, and the authors have no conflicts of interest directly relevant to the content of this study.
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Kokki, H., Purhonen, S., Teräsvirta, M. et al. Ketoprofen for Add-On Pain Treatment to Paracetamol after Strabismus Surgery in Children. Clin. Drug Investig. 24, 237–244 (2004). https://doi.org/10.2165/00044011-200424040-00005
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DOI: https://doi.org/10.2165/00044011-200424040-00005