Baron Elma D, Harris Lisbeth, Redpath William S, Shapiro Howard, Hetzel Fred, Morley Grant, Bar-Or David, Stevens Seth R
Department of Dermatology, University Hospitals of Cleveland/Case Western Reserve University, Cleveland, Ohio 44106, USA.
Arch Dermatol. 2003 Oct;139(10):1288-90. doi: 10.1001/archderm.139.10.1288.
To determine whether pretreatment of skin with erbium:YAG (Er:YAG) laser-assisted delivery facilitates the penetration of lidocaine cream to provide anesthesia suitable for needlesticks after just 5 minutes.
Trial 1 was a double-blind randomized controlled trial, whereas trial 2 was a nonblinded randomized controlled trial.
The study was conducted in 2 facilities, an academic and a private clinical research unit.
A total of 320 healthy volunteers, aged 18 to 65 years and of any Fitzpatrick skin phototype.
Trial 1 involved an Er:YAG laser pretreatment to disrupt the stratum corneum followed by an application of 4% lidocaine cream on one arm, and a laser pretreatment plus placebo on the other arm. Trial 2 involved an application of 4% lidocaine cream alone on one arm, and a laser pretreatment followed by an application of 4% lidocaine cream on the other arm.
Self-reported pain perception on a 100-mm visual analog scale after quick insertion and removal of a 25-gauge hypodermic needle on the treatment sites.
Data from the 2 trials showed that there was a 62% pain reduction with laser pretreatment plus lidocaine compared with laser pretreatment plus placebo, and a 61% pain reduction with laser pretreatment plus lidocaine, compared with lidocaine alone. The decrease in pain in both trials was statistically significant (P<.001). Adverse events reported 48 hours after treatment were few and mild.
Treatment with the Er:YAG laser followed by lidocaine cream is a safe, effective, and efficient means of inducing skin anesthesia that significantly reduces the pain of hypodermic needle insertion.
确定用铒:钇铝石榴石(Er:YAG)激光辅助给药对皮肤进行预处理是否能促进利多卡因乳膏的渗透,从而在仅5分钟后就能提供适合皮下注射的麻醉效果。
试验1为双盲随机对照试验,而试验2为非盲随机对照试验。
该研究在两个机构进行,一个是学术性临床研究单位,另一个是私立临床研究单位。
共有320名健康志愿者,年龄在18至65岁之间, Fitzpatrick皮肤光类型不限。
试验1包括用Er:YAG激光预处理以破坏角质层,然后在一只手臂上涂抹4%利多卡因乳膏,在另一只手臂上进行激光预处理加安慰剂。试验2包括在一只手臂上单独涂抹4%利多卡因乳膏,在另一只手臂上进行激光预处理后再涂抹4%利多卡因乳膏。
在治疗部位快速插入和拔出25号皮下注射针头后,通过100毫米视觉模拟量表自我报告的疼痛感知。
两项试验的数据显示,与激光预处理加安慰剂相比,激光预处理加利多卡因可使疼痛减轻62%;与单独使用利多卡因相比,激光预处理加利多卡因可使疼痛减轻61%。两项试验中疼痛的减轻均具有统计学意义(P<0.001)。治疗后48小时报告的不良事件很少且轻微。
先用Er:YAG激光治疗,再涂抹利多卡因乳膏,是一种安全、有效且高效的诱导皮肤麻醉的方法,可显著减轻皮下注射针头插入时的疼痛。