Department of Pharmacology and Toxicology, University of Kuopio, Kuopio, FinlandDepartment of Anaesthesiology and Intensive Care, Kuopio University Hospital, Kuopio, Finland.
Clin Drug Investig. 2004;24(4):237-44. doi: 10.2165/00044011-200424040-00005.
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.
A prospective, double-blind, randomised clinical trial.
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.
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.
Neither paracetamol nor ketoprofen-paracetamol provided sufficient analgesia for children after strabismus surgery because most needed rescue analgesia.
评估在接受斜视手术的儿童中，与单独使用扑热息痛相比，将非甾体抗炎镇痛药酮洛芬与扑热息痛联合使用是否能提供更好的术后镇痛效果。
前瞻性、双盲、随机临床试验。
56 名一般健康的儿童（年龄 3-15 岁）接受标准化气管内麻醉下的斜视手术，随机分配接受静脉注射酮洛芬 1mg/kg 或麻醉诱导时生理盐水，然后 3 小时后再给予第二剂。所有儿童在手术前 60 分钟口服扑热息痛 24mg/kg 溶液，并在手术期间静脉注射芬太尼 2μg/kg。对于前 6 小时疼痛（11 分制疼痛评分>3：0 = 无痛，10 = 最痛）的儿童，给予芬太尼 1μg/kg 静脉注射作为解救性镇痛。记录前 24 小时内所有呕吐发作和其他不良反应事件。
酮洛芬-扑热息痛组 27 名儿童中有 21 名（78%）和扑热息痛组 29 名儿童中有 23 名（79%）需要芬太尼解救镇痛。酮洛芬-扑热息痛组在前 6 小时内芬太尼的平均（SD）剂量为 1.2（0.9），扑热息痛组为 1.7（1.1）剂量（平均差异 0.5 剂量；95%CI 差异：-0.1，1.3；p=0.11）。酮洛芬-扑热息痛组有 8 名（30%）呕吐，扑热息痛组有 14 名（48%）（差异 19%；95%CI-6，44%；p=0.15）。没有发生严重不良事件。
在斜视手术后，扑热息痛或酮洛芬-扑热息痛都不能为儿童提供足够的镇痛效果，因为大多数儿童需要解救性镇痛。
