Kim Jarmila, Azavedo Lawrence, Bhananker Sanjay, Bonn Gary, Splinter William
Department of Anesthesiology, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.
Can J Anaesth. 2003 Oct;50(8):819-23. doi: 10.1007/BF03019379.
Corrective strabismus surgery is associated with moderate pain after surgery. Postoperative analgesia for these patients may include topical local anesthetic agents and topical non-steroidal anti-inflammatory drugs. In this prospective randomized, double-blind placebo controlled clinical trial we compared the effect of placebo to intraoperative 0.5% topical amethocaine or 0.5% topical ketorolac on pain control after strabismus surgery in children.
Following Institutional Ethics Committee approval and parental consent, we prospectively studied 51 healthy children between the ages of two and seven years who were undergoing elective bilateral recession surgery in a randomized, double-blind controlled clinical trial. Children were randomized to receive either placebo (normal saline), 0.5% amethocaine or 0.5% ketorolac eye drops at the start and end of strabismus repair surgery. Pain was assessed with a modified Children's Hospital of Eastern Ontario Pain Score in the recovery room. If the pain score was greater than 6, the patient was administered a single oral dose of acetaminophen (20 mg x kg(-1)).
The groups had similar demographic data. Duration of surgery and anesthesia, time spent in recovery room and length of hospital stay between the three groups were similar. Pain scores and analgesic requirements while in the hospital were also similar between the groups as was the time to first analgesic administration. There were no side effects observed in any of the three treatment arms.
We conclude that there is no improvement in postoperative pain control after the intraoperative administration of topical 0.5% ketorolac or 0.5% amethocaine when compared to placebo in children undergoing strabismus surgery.
斜视矫正手术术后会伴有中度疼痛。这些患者的术后镇痛可能包括局部麻醉剂和局部非甾体抗炎药。在这项前瞻性随机、双盲、安慰剂对照临床试验中，我们比较了安慰剂与术中使用0.5%丁卡因或0.5%酮咯酸对儿童斜视手术后疼痛控制的效果。
经机构伦理委员会批准并获得家长同意后，我们前瞻性地研究了51名年龄在2至7岁之间、正在接受择期双侧内直肌后退术的健康儿童，进行一项随机、双盲对照临床试验。在斜视修复手术开始和结束时，将儿童随机分为接受安慰剂（生理盐水）、0.5%丁卡因或0.5%酮咯酸滴眼液三组。在恢复室用改良的安大略东部儿童医院疼痛评分评估疼痛。如果疼痛评分大于6，患者将口服单剂量对乙酰氨基酚（20mg×kg⁻¹）。
三组的人口统计学数据相似。三组之间的手术和麻醉持续时间、在恢复室的时间以及住院时间相似。三组在住院期间的疼痛评分、镇痛需求以及首次给予镇痛剂的时间也相似。在三个治疗组中均未观察到副作用。
我们得出结论，在斜视手术儿童中，与安慰剂相比，术中给予0.5%酮咯酸或0.5%丁卡因对术后疼痛控制并无改善。
