Matsumoto Tomomi, Chaki Tomohiro, Hirata Naoyuki, Yamakage Michiaki
Department of Anesthesiology, Tomakomai City Hospital, 1-5-20, Shimizu-cho, Tomakomai, Hokkaido, Japan.
Department of Anesthesiology, Sapporo Medical University School of Medicine, 291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan.
JA Clin Rep. 2018 Oct 8;4(1):73. doi: 10.1186/s40981-018-0210-1.
Although venous cannulation is imperative during perioperative period, it inevitably causes venipuncture pain. Eutectic mixture local anesthetics (EMLA) has been used to reduce this pain, and various studies have been conducted to evaluate the efficacy of EMLA. But these studies did not elucidate the effect of EMLA exactly, because there were large individual differences in pain sensitivity. The aim of this study is to accurately evaluate the efficacy of EMLA cream for venipuncture pain relief compared with lidocaine tape in the same patients.
Participants were randomly allocated into EL or LE group. Participants received EMLA cream at one side dorsum of hand and lidocaine tape at another dorsum of hand before entering operation room. Local anesthetics were strictly applied according to their manufacturers' instruments, respectively. In the EL group, participants received venipuncture at EMLA cream site firstly. In LE group, participants, conversely, received venipuncture at lidocaine tape site firstly. Before anesthetic induction, local anesthetics were removed followed by venous cannulations. After cannulation, participants evaluated the pain by visual analog scale (VAS) and verbal rating scale (VRS).The primary outcome was VAS, and the secondary outcome was VRS.
Data from 24 patients were analyzed. The VAS of EMLA cream was significantly lower than that of lidocaine tape (4 [0-18] vs 17 [8-45], p = 0.001, 95% CI - 25 to - 6). The VRS of EMLA cream was also significantly lower than that of lidocaine tape (2 [1-2] vs 2 [2-3], p = 0.002, 95% CI - 0.8 to - 0.2). The local skin adverse events were observed in five patients at EMLA cream applied hands.
We conducted a comparative study to elucidate the efficacy of EMLA cream for venipuncture-pain comparing with lidocaine tape in the same patients. Our results strongly suggest that EMLA cream is more effective for venipuncture pain relief than lidocaine tape.
UMIN Clinical Trials Registry, UMIN000023030 . Registered 5 July 2016.
尽管围手术期静脉置管必不可少，但不可避免地会引起静脉穿刺疼痛。复方利多卡因局部麻醉剂（EMLA）已被用于减轻这种疼痛，并且已经进行了各种研究来评估EMLA的疗效。但这些研究并未确切阐明EMLA的效果，因为疼痛敏感性存在很大的个体差异。本研究的目的是在同一患者中，准确评估EMLA乳膏与利多卡因贴剂相比缓解静脉穿刺疼痛的疗效。
参与者被随机分为EL组或LE组。在进入手术室前，参与者在一侧手背涂抹EMLA乳膏，在另一侧手背贴上利多卡因贴剂。局部麻醉剂分别严格按照其制造商的说明使用。在EL组中，参与者首先在涂抹EMLA乳膏的部位进行静脉穿刺。相反，在LE组中，参与者首先在贴有利多卡因贴剂的部位进行静脉穿刺。在麻醉诱导前，去除局部麻醉剂，然后进行静脉置管。置管后，参与者通过视觉模拟评分法（VAS）和语言评定量表（VRS）评估疼痛程度。主要结局指标是VAS，次要结局指标是VRS。
分析了24例患者的数据。EMLA乳膏的VAS评分显著低于利多卡因贴剂（4[0 - 18]对17[8 - 45]，p = 0.001，95%CI - 25至 - 6）。EMLA乳膏的VRS评分也显著低于利多卡因贴剂（2[1 - 2]对2[2 - 3]，p = 0.002，95%CI - 0.8至 - 0.2）。在涂抹EMLA乳膏的手上，有5例患者出现了局部皮肤不良事件。
我们进行了一项对比研究，以阐明在同一患者中EMLA乳膏与利多卡因贴剂相比缓解静脉穿刺疼痛的疗效。我们的结果有力地表明，EMLA乳膏在缓解静脉穿刺疼痛方面比利多卡因贴剂更有效。
UMIN临床试验注册中心，UMIN000023030。2016年7月5日注册。
