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一项关于EMLA贴片用于减轻4至6岁儿童肌肉注射相关疼痛的随机双盲、安慰剂对照试验。

A randomized double-blind, placebo-controlled trial of the EMLA patch for the reduction of pain associated with intramuscular injection in four to six-year-old children.

作者信息

Cassidy K L, Reid G J, McGrath P J, Smith D J, Brown T L, Finley G A

机构信息

Department of Medicine, Izaak Walton Killam Health Centre, and Dalhousie University, Halifax, Nova Scotia, Canada.

出版信息

Acta Paediatr. 2001 Nov;90(11):1329-36. doi: 10.1080/080352501317130416.

DOI:10.1080/080352501317130416
PMID:11808908
Abstract

UNLABELLED

The effectiveness of a eutectic mixture lidocaine-prilocaine topical anaesthetic cream (EMLA) patch compared with a placebo patch in the reduction of pain associated with intramuscular immunization was evaluated. As part of the study, 161 children (aged 4-6-y) undergoing routine diphtheria, pertussis, tetanus and polio (DPTP) immunization in five urban and five rural private office settings were randomly assigned to an EMLA patch (n = 83) or a placebo patch control group (n = 78). Pain measurements included: child's self-report on a Faces Pain Scale; facial action on the Child Facial Coding System; the Children's Hospital of Eastern Ontario Pain Scale and parent and technician ratings on a Visual Analogue Scale. Parents also rated their own and their child's immunization-related anxiety on a Visual Analogue Scale. The EMLA patch group had significantly less pain on all four pain measures compared with the placebo group. Of the children in the placebo group, 43% had clinically significant pain, compared with 17% of children in the EMLA patch group. No severe adverse symptoms occurred as a result of either EMLA or placebo patch application.

CONCLUSION

The EMLA patch reduced immunization pain in 4 to 6-y-old children during needle injection.

摘要

未贴标签

评估了复方利多卡因-丙胺卡因局部麻醉乳膏(EMLA)贴剂与安慰剂贴剂相比在减轻肌肉注射免疫相关疼痛方面的有效性。作为研究的一部分,在五个城市和五个农村私人诊所环境中接受常规白喉、百日咳、破伤风和脊髓灰质炎(DPTP)免疫接种的161名儿童(4至6岁)被随机分配到EMLA贴剂组(n = 83)或安慰剂贴剂对照组(n = 78)。疼痛测量包括:儿童使用面部疼痛量表的自我报告;儿童面部编码系统的面部动作;东安大略儿童医院疼痛量表以及家长和技术人员使用视觉模拟量表的评分。家长还使用视觉模拟量表对他们自己和孩子与免疫接种相关的焦虑进行评分。与安慰剂组相比,EMLA贴剂组在所有四项疼痛测量中疼痛明显减轻。安慰剂组中有43%的儿童有临床显著疼痛,而EMLA贴剂组中这一比例为17%。使用EMLA或安慰剂贴剂均未出现严重不良症状。

结论

EMLA贴剂减轻了4至6岁儿童在注射疫苗时的免疫接种疼痛。

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