Hannu Kokki1, Sinikka Purhonen, Markku Teräsvirta, Paula Ylönen. 1. Department of Pharmacology and Toxicology, University of Kuopio, Kuopio, FinlandDepartment of Anaesthesiology and Intensive Care, Kuopio University Hospital, Kuopio, Finland.
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 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 theketoprofen-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.
RCT Entities:
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.
Authors: Mark T Holdsworth; Richard E Fichtl; Maryam Behta; Dennis W Raisch; Elena Mendez-Rico; Alexa Adams; Melanie Greifer; Susan Bostwick; Bruce M Greenwald Journal: Arch Pediatr Adolesc Med Date: 2003-01