一项随机双盲安慰剂对照研究,比较新型抗癫痫药拉莫三嗪在大手术患者中的先发制人镇痛效果

P. Shah, U. Bhosale, Ankush Gupta, R. Yegnanarayan, S. Sardesai
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引用次数: 3

摘要

背景:如果术后急性疼痛得不到缓解,可能会导致严重的发病率和死亡率。术前开始的先发制人的镇痛提供了提前的镇痛,甚至在暴露于最初的有害刺激,给予有效的术后镇痛。在发达国家,它经常作为明确规定的协议的一部分进行实践。然而,在我国,只有少数几个中心实行这种做法,而且不定期,没有明确的协议。很少有研究支持新型抗癫痫药加巴喷丁的先发制人镇痛效果。虽然拉莫三嗪在慢性疼痛的动物模型和加巴喷丁耐药神经性疼痛的临床研究中是一种被证实的镇痛药,但文献检索显示其预防性镇痛效果的数据很少。目的:本研究旨在研究拉莫三嗪与双氯芬酸钠在术后疼痛控制中的先发制人镇痛效果。材料与方法:本随机临床试验纳入了90例年龄在18岁至70岁之间接受大手术的男女患者。将患者随机分为安慰剂组、对照组和试验组,分别在麻醉诱导前30 min进行治疗。采用视觉模拟量表(VAS)、面部评分量表(FRS)和行为评分量表(BRS)分别记录醒时及醒后1、2、4、6、24小时的Aldrete评分和疼痛评分。记录术后24小时抢救镇痛药消耗情况。结果:安慰剂组术后2 h各疼痛评分均显著高于对照组(P < 0.05),对照组术后1 h疼痛评分均显著高于对照组(P < 0.05)。实验组患者在整个研究过程中更舒适,术后镇痛需求明显减少(P < 0.05)。结论:本研究推荐单次口服拉莫三嗪作为先发制人的镇痛药,可有效控制术后疼痛。
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A Randomized Double-Blind Placebo-Controlled Study to Compare Preemptive Analgesic Efficacy of Novel Antiepileptic Agent Lamotrigine in Patients Undergoing Major Surgeries
Background: If postoperative acute pain remains unrelieved, it may result in significant morbidity and mortality. Preemptive analgesic initiated before surgery offers premature analgesia even before exposure to an initial noxious stimulus bestowing effective postoperative analgesia. In developed countries, it is regularly practiced as a part of well-defined protocol. In our country however, only a few centers practice it and that too irregularly and with undefined protocol. Few studies support preemptive analgesic efficacy of novel antiepileptic agent gabapentin. Though lamotrigine is a proven analgesic in animal models of chronic pain and clinical studies of gabapentin-resistant neuropathic pain, a literature search revealed scarce data on its preemptive analgesic efficacy. Aims: The present study is designed to study the preemptive analgesic efficacy of lamotrigine in comparison with diclofenac sodium in postoperative pain control. Materials and Methods: This randomized clinical trial included 90 patients of both sexes, between 18 years and 70 years undergoing major surgeries. Patients were randomly allocated into placebo, control, and test groups and received the respective treatment 30 min before the induction of anesthesia. Aldrete score and pain score were recorded using visual analog scale (VAS), facial rating scale (FRS), and behavioral rating scale (BRS) at awakening and at 1 h, 2 h, 4 h, 6 h, and 24 h. Postoperative rescue analgesic consumption for 24 h was recorded. Results: Significantly higher pain scores were observed in the placebo group postoperatively for 2 h on all pain scales (P < 0.05), whereas in the control group it was significantly higher at 1 h (P < 0.05). The test group patients were more comfortable throughout the study and postoperative analgesic requirement was significantly less (P < 0.05). Conclusions: The study recommends the use of single oral dose lamotrigine as preemptive analgesic for effective postoperative pain control.
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