Avcu Nazire, Doğan Nurettin Özgür, Pekdemir Murat, Yaka Elif, Yılmaz Serkan, Alyeşil Cansu, Akalın Latif Erdem
Department of Emergency Medicine, Bitlis State Hospital, Bitlis, Turkey.
Department of Emergency Medicine, Faculty of Medicine, Kocaeli University, Kocaeli, Turkey.
Ann Emerg Med. 2017 Jun;69(6):743-751. doi: 10.1016/j.annemergmed.2016.09.031. Epub 2016 Nov 23.
The study aims to evaluate the efficacy and safety of intranasal lidocaine administration for migraine treatment.
This single-center, double-blind, randomized, controlled trial was conducted in a tertiary care emergency department. Included patients met the migraine criteria of the International Headache Society. Patients were randomized to intranasal lidocaine or saline solution; all participants received 10 mg of intravenous metoclopramide. Patient pain intensity was assessed with an 11-point numeric rating scale score. The primary outcome measure was the change in pain scores at 15 minutes; secondary outcomes were changes in pain intensity after pain onset and need for rescue medication.
Patients (n=162) were randomized into 2 groups with similar baseline migraine characteristics and numeric rating scale scores. The median reduction in numeric rating scale score at 15 minutes was 3 (interquartile range [IQR] 2 to 5) for the lidocaine group and 2 (IQR 1 to 4) for the saline solution group (median difference=1.0; 95% confidence interval 0.1 to 2.1). The reduction in pain score at 30 minutes was 4 (IQR 3 to 7) for the lidocaine group and 5 (IQR 2 to 7) for the saline solution group (median difference=1.0; 95% confidence interval 0.1 to 2.1). Need for rescue medication did not differ between the groups, and local irritation was the most common adverse event in the lidocaine group.
Although intranasal lidocaine was found no more efficacious than normal saline solution in our study, future studies should focus on patients who present earlier after headache onset.
本研究旨在评估鼻内给予利多卡因治疗偏头痛的疗效和安全性。
本单中心、双盲、随机对照试验在一家三级医疗急诊科进行。纳入的患者符合国际头痛协会的偏头痛标准。患者被随机分为鼻内给予利多卡因组或生理盐水组；所有参与者均接受10毫克静脉注射甲氧氯普胺。采用11点数字评定量表评分评估患者疼痛强度。主要结局指标为15分钟时疼痛评分的变化；次要结局指标为疼痛发作后疼痛强度的变化以及是否需要使用急救药物。
162例患者被随机分为2组，两组患者的基线偏头痛特征和数字评定量表评分相似。利多卡因组15分钟时数字评定量表评分的中位数降低3分（四分位间距[IQR]为2至5），生理盐水组为2分（IQR为1至4）（中位数差值 = 1.0；95%置信区间为0.1至2.1）。利多卡因组30分钟时疼痛评分降低4分（IQR为3至7），生理盐水组为5分（IQR为2至7）（中位数差值 = 1.0；95%置信区间为0.1至2.1）。两组患者使用急救药物的需求无差异，利多卡因组最常见的不良事件为局部刺激。
尽管在我们的研究中发现鼻内给予利多卡因并不比生理盐水更有效，但未来的研究应聚焦于头痛发作后就诊较早的患者。
