Katz Nathaniel P, Shapiro David E, Herrmann Timothy E, Kost Joseph, Custer Linda M
From the Pain Trials Center, Brigham & Women's Hospital, Boston, Massachusetts.
Anesth Analg. 2004 Feb;98(2):371-376. doi: 10.1213/01.ANE.0000099716.02783.C4.
In this randomized, double-blinded, placebo-controlled, crossover trial of 42 human subjects, we examined the speed of onset of cutaneous anesthesia by eutectic mixture of local anesthetics (EMLA) cream after brief (approximately 10-s) pretreatment of the underlying skin with low-frequency (55 kHz) ultrasound. Four treatments were compared: ultrasound pretreatment followed by application of 1 g EMLA or placebo cream for 5 min, 10 min, 15 min, and 60 min without ultrasound pretreatment as positive control. Pain was tested by pricks with a 20 g needle. Pain scores and patient preference for EMLA or placebo cream were measured at each time point. Based on both pain scores and patient preference, cutaneous anesthesia was achieved in the EMLA groups as compared with placebo at all time points. After ultrasound pretreatment and then 5, 10, or 15 min after EMLA cream application, pain scores and overall preference were statistically indistinguishable from EMLA cream application for 60 min (without ultrasound pretreatment). There were no significant adverse effects. Low-frequency ultrasound pretreatment appears to be safe and effective in producing rapid onset of EMLA cream in this model, with results as early as 5 min.
A prospective, randomized, double-blinded, placebo-controlled clinical trial demonstrated rapid onset of cutaneous anesthesia by pretreatment of the skin with ultrasound before application of EMLA cream.
在这项针对42名人类受试者的随机、双盲、安慰剂对照交叉试验中,我们研究了在对皮下皮肤进行短暂(约10秒)的低频(55千赫兹)超声预处理后,复方利多卡因乳膏(EMLA)产生皮肤麻醉起效的速度。比较了四种处理方式:超声预处理后分别涂抹1克EMLA或安慰剂乳膏5分钟、10分钟、15分钟,以及不进行超声预处理涂抹EMLA或安慰剂乳膏60分钟作为阳性对照。用20G针头刺痛来测试疼痛。在每个时间点测量疼痛评分以及患者对EMLA或安慰剂乳膏的偏好。基于疼痛评分和患者偏好,在所有时间点,EMLA组与安慰剂组相比均实现了皮肤麻醉。经过超声预处理,然后在涂抹EMLA乳膏后5分钟、10分钟或15分钟时,疼痛评分和总体偏好与涂抹EMLA乳膏60分钟(不进行超声预处理)在统计学上无显著差异。没有明显的不良反应。在该模型中,低频超声预处理在使EMLA乳膏快速起效方面似乎是安全有效的,最早在5分钟时就有效果。
一项前瞻性、随机、双盲、安慰剂对照的临床试验表明,在涂抹EMLA乳膏之前用超声预处理皮肤可使皮肤麻醉快速起效。