Taddio A, Nulman I, Goldbach M, Ipp M, Koren G
Division of Clinical Pharmacology and Toxicology, Hospital for Sick Children, Toronto, Ontario, Canada.
J Pediatr. 1994 Apr;124(4):643-8. doi: 10.1016/s0022-3476(05)83150-6.
To determine whether use of lidocaine-prilocaine 5% cream (EMLA) decreases pain associated with diphtheria-pertussis-tetanus (DPT) vaccination in infants.
Randomize, double-blind, controlled trial in outpatient pediatric practice, Toronto, Ontario, Canada. Before vaccination, parents applied 2.5 gm of EMLA or placebo to the infant's leg and covered it with an occlusive dressing for at least 60 minutes. The infant received a 0.5 ml intramuscular injection of DPT at 2 degree to 8 degree C with a 1.6 cm 25-gauge needle; the infant was videotaped. The Modified Behavioral Pain Scale (MBPS) was used to assess baseline and postvaccination pain scores. Latency and duration of infant cry were also measured.
A total of 49 evaluable infants received EMLA, and 47 infants received placebo. There were no significant differences in demographic data; mean age was 5 months; and 50% of the subjects were male. The median difference in pre-vaccination and postvaccination MBPS scores was lower for EMLA than for placebo (p = 0.001). The latency to the first cry was longer for subjects who were treated with EMLA (p = 0.0004)), but the total crying time was shorter (10.3 seconds vs 25.2 seconds; p = 0.027). Of the study group, 90% (45/50) of subjects treated with EMLA and 12% (6/49) of subjects treated with placebo had local skin reactions (p < 0.0001), mainly skin blanching.
Pretreatment with EMLA decreases infant pain from DPT vaccinations. Application of these data is limited to healthy infants receiving DPT vaccinations.
确定使用5%利多卡因-丙胺卡因乳膏（EMLA）是否能减轻婴儿白喉-百日咳-破伤风（DPT）疫苗接种相关的疼痛。
在加拿大多伦多的门诊儿科诊所进行随机、双盲、对照试验。接种疫苗前，家长将2.5克EMLA或安慰剂涂抹在婴儿腿部，并用封闭敷料覆盖至少60分钟。婴儿在2至8摄氏度下用1.6厘米25号针头接受0.5毫升的DPT肌肉注射；对婴儿进行录像。使用改良行为疼痛量表（MBPS）评估基线和接种疫苗后的疼痛评分。还测量了婴儿哭泣的潜伏期和持续时间。
共有49名可评估婴儿接受了EMLA治疗，47名婴儿接受了安慰剂治疗。人口统计学数据无显著差异；平均年龄为5个月；50%的受试者为男性。接种疫苗前和接种疫苗后MBPS评分的中位数差异，EMLA组低于安慰剂组（p = 0.001）。接受EMLA治疗的受试者首次哭泣的潜伏期更长（p = 0.0004），但总哭泣时间更短（10.3秒对25.2秒；p = 0.027）。在研究组中，接受EMLA治疗的受试者中有90%（45/50）和接受安慰剂治疗的受试者中有12%（6/49）出现局部皮肤反应（p < 0.0001），主要是皮肤变白。
EMLA预处理可减轻婴儿DPT疫苗接种引起的疼痛。这些数据的应用仅限于接受DPT疫苗接种的健康婴儿。
