Tuomilehto H, Kokki H
Department of Otorhinolaryngology, Kuopio University Hospital, Kuopio, Finland.
Acta Anaesthesiol Scand. 2002 Feb;46(2):184-9. doi: 10.1034/j.1399-6576.2002.460211.x.
Different parenteral routes of administration of NSAIDs such as ketoprofen have not been properly compared in children. This study was designed to compare the analgesic efficacy of intravenous and intramuscular ketoprofen for pain management in children after day-case adenoidectomy.
A total of 120 children, aged 1-9 years, who were scheduled to undergo adenoidectomy, were randomized to receive ketoprofen 2 mg/kg either intravenously with intramuscular placebo (n = 40) or ketoprofen 2 mg/kg intramuscularly with intravenous placebo (n = 40), or both intravenous and intramuscular placebo (n = 40) at induction of anesthesia. The study design was prospective and double-blind with parallel groups. Pain was assessed at rest and during swallowing using the Maunuksela pain scale during 3 h after surgery, and fentanyl i.v. was given for rescue analgesia.
Children in the Placebo group needed significantly more doses of fentanyl (72 doses) than either children in the intravenous group (47 doses) or children in the intramuscular group (51 doses) (P = 0.021). In addition, a higher proportion of children in the Placebo group than in the two ketoprofen groups (P = 0.03) demanded rescue analgesic. No difference in the need for rescue analgesia or in pain scores was found between the two ketoprofen groups. Children in the intravenous group had less pain than children in the Placebo group. The difference was significant during swallowing at 1 h after surgery (P = 0.046) and for the worst pain observed during swallowing for 3 h after surgery (P = 0.022). There were no differences between the three groups with respect to operation times, amount of perioperative bleeding, or rate or extent of adverse events.
The efficacy of intravenous and intramuscular ketoprofen was similar, and they both differed from placebo.
非甾体抗炎药（如酮洛芬）不同的肠胃外给药途径在儿童中尚未得到充分比较。本研究旨在比较静脉注射和肌肉注射酮洛芬对日间手术腺样体切除术后儿童疼痛管理的镇痛效果。
总共120名年龄在1至9岁、计划接受腺样体切除术的儿童，被随机分为三组，分别在麻醉诱导时接受静脉注射2mg/kg酮洛芬加肌肉注射安慰剂（n = 40）、肌肉注射2mg/kg酮洛芬加静脉注射安慰剂（n = 40）或静脉注射和肌肉注射均为安慰剂（n = 40）。研究设计为前瞻性双盲平行组试验。术后3小时内，使用莫努克塞拉疼痛量表评估静息和吞咽时的疼痛情况，静脉注射芬太尼用于补救镇痛。
安慰剂组儿童所需芬太尼剂量（72剂）显著多于静脉注射组儿童（47剂）或肌肉注射组儿童（51剂）（P = 0.021）。此外，安慰剂组中需要补救镇痛的儿童比例高于两个酮洛芬组（P = 0.03）。两个酮洛芬组在补救镇痛需求或疼痛评分方面没有差异。静脉注射组儿童的疼痛程度低于安慰剂组儿童。这种差异在术后1小时吞咽时显著（P = 0.046），在术后3小时吞咽时观察到的最严重疼痛方面也显著（P = 0.022）。三组在手术时间、围手术期出血量或不良事件发生率及程度方面没有差异。
静脉注射和肌肉注射酮洛芬的疗效相似，且均与安慰剂不同。
