Paschos Ekaterini, Huth K C, Benz C, Reeka-Bardschmidt A, Hickel R
Department of Orthodontics, Dental School, LMU-University Munich, Goethestr. 70, 80336 München, Germany.
J Dent. 2006 Jul;34(6):398-404. doi: 10.1016/j.jdent.2005.09.002. Epub 2005 Oct 18.
The literature reports mixed results regarding the efficacy of intraoral topical anesthetics. Only a few studies have been performed in children. Some non-placebo controlled studies have been carried out to compare the efficacy in reducing children's injection pain between different topical anesthetics
In a randomized, double blind, placebo controlled study with split-mouth design 104 children were enrolled to evaluate the efficacy of four topical anesthetics (Gingicain Spray, Gingicaine Topical Anesthetic, Legecain-Solution, EMLA Crème) when used prior to buccal injections within the conservative treatment of carious upper primary molars. The heart rate change and a Face Pain Scale were used as primary variables. The Visual Analog Scale, the modified Children's Hospital Pain Scale and the Sound-Eyes-Motor Scale were also evaluated.
There was no significant difference between the placebo and any corresponding topical anesthetic with regard to the primary variables (HRC and FPS). A significant difference was found in favour of Gingicain Spray and Gingicaine Topical Anesthetic according to secondary variables (VAS, S(E)MS).
While the secondary variables point to a benefit of the topical anesthetics Gingicain Spray and Gingicaine Topical Anesthetic compared to placebo, the results of the primary variables showed no differences in effectiveness of topical anesthetics and their corresponding placebos.
关于口腔内局部麻醉剂的疗效,文献报道的结果不一。仅对少数儿童进行了研究。已开展一些非安慰剂对照研究,以比较不同局部麻醉剂在减轻儿童注射疼痛方面的疗效。
在一项采用双盲、安慰剂对照、口内分侧设计的随机研究中,纳入104名儿童,以评估四种局部麻醉剂(Gingicain喷雾、Gingicaine局部麻醉剂、Legecain溶液、EMLA乳膏)在对龋坏的上颌乳磨牙进行保守治疗时,于颊部注射前使用的疗效。心率变化和面部疼痛量表用作主要变量。还评估了视觉模拟量表、改良的儿童医院疼痛量表和声-眼-动量表。
在主要变量(心率变化和面部疼痛量表)方面,安慰剂与任何相应的局部麻醉剂之间无显著差异。根据次要变量(视觉模拟量表、声-眼-动量表),发现Gingicain喷雾和Gingicaine局部麻醉剂具有显著优势。
虽然次要变量表明局部麻醉剂Gingicain喷雾和Gingicaine局部麻醉剂与安慰剂相比有优势,但主要变量的结果显示局部麻醉剂与其相应安慰剂在有效性方面无差异。