局部麻醉药复方制剂乳膏用于健康早产儿静脉穿刺的随机对照试验。
Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants.
作者信息
Acharya A B, Bustani P C, Phillips J D, Taub N A, Beattie R M
机构信息
Department of Paediatrics, Peterborough District Hospital.
出版信息
Arch Dis Child Fetal Neonatal Ed. 1998 Mar;78(2):F138-42. doi: 10.1136/fn.78.2.f138.
AIM
To assess the safety and efficacy of EMLA cream (eutectic mixture of local anaesthetics) used to induce surface anaesthesia for venepuncture in healthy preterm infants.
METHODS
Nineteen infants, median gestational age 31 weeks (range 26-33 weeks) were assessed in a randomised, double blind, placebo controlled, cross-over trial. Changes in physiological variables (heart rate, blood pressure, oxygen saturation) and behavioural responses (neonatal facial coding system score, crying time) before and after venepuncture with EMLA cream were compared with those obtained with a placebo cream to assess efficacy. Toxicity was assessed by comparing methaemoglobin concentrations at 1 hour and 8 hours after application.
RESULTS
There was no significant difference in efficacy between EMLA and placebo creams in physiological and behavioural responses. There was no significant difference in methaemoglobin concentrations one hour after the cream had been applied. At eight hours, however, concentrations were significantly higher after EMLA than placebo (p = 0.016). There was no evidence of clinical toxicity.
CONCLUSION
This study does not support the routine use of EMLA for venepuncture in healthy preterm infants.
目的
评估复方利多卡因乳膏（局部麻醉药的共熔混合物）用于健康早产儿静脉穿刺表面麻醉的安全性和有效性。
方法
在一项随机、双盲、安慰剂对照、交叉试验中对19例中位胎龄31周（范围26 - 33周）的婴儿进行了评估。将使用复方利多卡因乳膏静脉穿刺前后的生理变量（心率、血压、血氧饱和度）和行为反应（新生儿面部编码系统评分、哭闹时间）与使用安慰剂乳膏时获得的结果进行比较，以评估有效性。通过比较用药后1小时和8小时的高铁血红蛋白浓度来评估毒性。
结果
复方利多卡因乳膏与安慰剂乳膏在生理和行为反应方面的有效性无显著差异。用药1小时后高铁血红蛋白浓度无显著差异。然而，在8小时时，复方利多卡因乳膏后的浓度显著高于安慰剂（p = 0.016）。没有临床毒性的证据。
结论
本研究不支持在健康早产儿静脉穿刺中常规使用复方利多卡因乳膏。
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