Departments of Health Research Methods, Evidence, and Impact and
Pediatrics, McMaster University, Hamilton, Canada.
Pediatrics. 2019 Jan;143(1). doi: 10.1542/peds.2018-1173.
: media-1vid110.1542/5852339542001PEDS-VA_2018-1173 CONTEXT: The eutectic mixture of lidocaine (EMLA) cream has been used to reduce the pain during venipuncture in infants.
To determine the efficacy and safety of EMLA in infants <3 months of age requiring venipuncture in comparison with nonpharmacological interventions in terms of pain reduction, change in physiologic variables, and methemoglobinemia.
Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and gray literature were searched from inception to August 2017, without language restrictions.
We selected randomized controlled trials in which researchers compared EMLA with nonpharmacological interventions.
Two reviewers independently performed abstract screening and full-text review, and extracted the data and assessed the risk of bias.
Ten randomized controlled trials (907 infants) were included. EMLA revealed little or no effect in reduction of pain (standardized mean difference: 0.14; 95% confidence interval [CI]: -0.17 to 0.45; 6 trials, = 742; moderate-quality evidence) when EMLA was compared with sucrose, breastfeeding, or placebo. In comparison with placebo, EMLA revealed a small-to-moderate effect on increasing methemoglobin levels (mean difference: 0.35; 95% CI: 0.04 to 0.66; 2 trials, = 134; low-quality evidence). There was an increased risk of blanching of the skin in the EMLA group (relative risk: 2.63; 95% CI: 1.58 to 4.38; 2 trials, = 123; I = 84%, very low-quality evidence).
Our results may not be applicable to older infants.
EMLA reveals minimal benefits in terms of reduction of pain due to venipuncture procedure in comparison with placebo and no benefit in comparison with sucrose and/or breastfeeding. Moreover, it produced an elevation in methemoglobin levels and skin blanching.
：：媒体-1vid110.1542/5852339542001PEDSVAV_2018-1173 背景：利多卡因（EMLA）乳膏的共晶混合物已被用于减轻婴儿静脉穿刺时的疼痛。
：：目的：与非药物干预措施相比，确定 EMLA 在 <3 个月大需要静脉穿刺的婴儿中的疗效和安全性，以减少疼痛、生理变量的变化和高铁血红蛋白血症。
：：数据来源：从成立到 2017 年 8 月，检索了 Medline、Embase、Cochrane 对照试验中心注册库、护理和联合健康文献累积索引、Web of Science 和灰色文献，无语言限制。
：：研究选择：我们选择了将 EMLA 与非药物干预措施进行比较的随机对照试验。
：：数据提取：两名评审员独立进行了摘要筛选和全文审查，并提取了数据并评估了偏倚风险。
：：结果：纳入了 10 项随机对照试验（907 名婴儿）。与蔗糖、母乳喂养或安慰剂相比，EMLA 对减轻疼痛几乎没有效果（标准化均数差：0.14；95%置信区间[CI]：-0.17 至 0.45；6 项试验， = 742；中等质量证据）。与安慰剂相比，EMLA 对增加高铁血红蛋白水平有小到中等的影响（平均差异：0.35；95%CI：0.04 至 0.66；2 项试验， = 134；低质量证据）。在 EMLA 组中，皮肤苍白的风险增加（相对风险：2.63；95%CI：1.58 至 4.38；2 项试验， = 123；I = 84%，极低质量证据）。
：：局限性：我们的结果可能不适用于年龄较大的婴儿。
：：结论：与安慰剂相比，EMLA 在减轻静脉穿刺引起的疼痛方面几乎没有益处，与蔗糖和/或母乳喂养相比也没有益处。此外，它会导致高铁血红蛋白水平升高和皮肤苍白。
