Department of Anaesthesia and Intensive Care, Royal Papworth Hospital, Cambridge, United Kingdom.
Department of Anaesthesia, 67587Christchurch Hospital, Christchurch Hospital, Christchurch, New Zealand.
Anaesth Intensive Care. 2021 Nov;49(6):468-476. doi: 10.1177/0310057X211039227. Epub 2021 Nov 12.
Peripheral venous cannulation (PVC) is a commonly performed invasive medical procedure. Topical treatments such as the eutectic mixture of local anaesthetics (EMLA®, Aspen Pharmacare Australia Pty Ltd, St Leonards, NSW) attenuate the associated pain, but are limited by requiring up to one hour of application before becoming effective. The Coolsense® (Coolsense Medical Ltd., Tel Aviv, Israel) pain numbing applicator is a new device using a cryoanalgesic means to anaesthetise skin within seconds. Coolsense is being increasingly used for cannulation, but comparative studies are lacking. We recruited 64 healthy adult volunteers to this open-label two sequence, two period randomised crossover trial. Participants had two 20 gauge venous cannulae inserted, one on the dorsum of each hand. Each cannulation attempt was preceded by treatment with Coolsense or an EMLA patch containing 2.5% lidocaine and 2.5% prilocaine. The primary outcome was participant pain using the 0-10 numerical pain rating scale. Secondary outcomes were participant satisfaction scores on a 0-10 scale, treatment preference, and failed cannulation attempts. Participants were randomly assigned to either the Coolsense EMLA ( = 32) or EMLA Coolsense ( = 32) sequence. All participants completed the trial. The pooled mean paired difference of the numerical pain rating scale was -1.84 (95% confidence intervals -1.28 to -2.41; < 0.001) in favour of EMLA. The pooled mean paired difference for satisfaction score was 2.26 (95% confidence intervals 1.46 to 3.07; < 0.001) higher with EMLA. Most participants preferred EMLA over Coolsense ( < 0.001). There was no significant difference regarding failed cannulation between the two treatments ( = 0.14). Among healthy individuals undergoing elective PVC, EMLA was associated with reduced pain, increased satisfaction, and was the preferred treatment compared to Coolsense.
外周静脉置管术（PVC）是一种常见的有创性医疗程序。局部麻醉剂的共晶混合物（EMLA ® ，Aspen Pharmacare Australia Pty Ltd，St Leonards，新南威尔士州）等局部治疗方法可减轻相关疼痛，但由于需要在起效前应用长达一小时，因此受到限制。Coolsense ® （Coolsense Medical Ltd.，以色列特拉维夫）疼痛麻木敷贴器是一种新的设备，它使用冷冻镇痛手段在几秒钟内麻醉皮肤。Coolsense 越来越多地用于置管，但缺乏比较研究。我们招募了 64 名健康成年志愿者参加这项开放标签的两序列、两期随机交叉试验。参与者的双手背部各插入两根 20 号静脉置管。每次置管尝试前，先用 Coolsense 或含 2.5%利多卡因和 2.5%丙胺卡因的 EMLA 贴剂进行治疗。主要结局是使用 0-10 数字疼痛评分量表评估参与者的疼痛。次要结局包括参与者在 0-10 评分量表上的满意度评分、治疗偏好和置管失败尝试。参与者随机分配到 Coolsense EMLA（ = 32）或 EMLA Coolsense（ = 32）序列。所有参与者均完成了试验。数字疼痛评分量表的平均配对差值为-1.84（95%置信区间-1.28 至-2.41； < 0.001），有利于 EMLA。EMLA 的满意度评分平均配对差值为 2.26（95%置信区间 1.46 至 3.07； < 0.001）更高。大多数参与者更喜欢 EMLA 而不是 Coolsense（ < 0.001）。两种治疗方法在置管失败方面无显著差异（ = 0.14）。在接受择期 PVC 的健康个体中，与 Coolsense 相比，EMLA 可减轻疼痛、提高满意度，是首选治疗方法。
