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一项随机双盲试验:比较无针注射利多卡因与局部麻醉用于婴儿腰椎穿刺。

A Randomized Double Blind Trial of Needle-free Injected Lidocaine Versus Topical Anesthesia for Infant Lumbar Puncture.

机构信息

Section of Pediatric Emergency Medicine, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO.

Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO.

出版信息

Acad Emerg Med. 2018 Mar;25(3):310-316. doi: 10.1111/acem.13351. Epub 2017 Dec 26.

DOI:10.1111/acem.13351
PMID:29160002
Abstract

OBJECTIVES

Lumbar punctures (LPs) are commonly performed in febrile infants to evaluate for meningitis, and local anesthesia increases the likelihood of LP success. Traditional methods of local anesthesia require injection that may be painful or topical application that is not effective immediately. Recent advances in needle-free jet injection may offer a rapid alternative to these modalities. We compared a needle-free jet-injection system (J-Tip) with 1% buffered lidocaine to topical anesthetic (TA) cream for local anesthesia in infant LPs.

METHODS

This was a single-center randomized double-blind trial of J-Tip versus TA for infant LPs in an urban tertiary care children's hospital emergency department. A computer randomization model was used to allocate patients to either intervention. Patients aged 0 to 4 months were randomized to J-Tip syringe containing 1% lidocaine and a placebo TA cream or J-Tip syringe containing saline and TA. The primary outcome was the difference between the Neonatal Faces Coding Scale (NFCS) before the procedure and during LP needle insertion. Secondary outcomes included changes in heart rate (HR) and NFCS throughout the procedure, difficulty with LP, number of LP attempts, provider impression of pain control, additional use of lidocaine, skin changes at LP site, and LP success.

RESULTS

We enrolled 66 subjects; 32 were randomized to J-Tip with lidocaine and 34 to EMLA. Six participants were excluded from the final analysis due to age greater than 4 months, and the remaining 58 were analyzed in their respective groups (32 J-Tip, 34 TA). There was no difference detected in NFCS between the two treatment groups before the procedure and during needle insertion for the LP (p = 0.58, p = 0.37). Neither HR nor NCFS differed among the groups throughout the procedure. Median perception of pain control by the provider and the need for additional lidocaine were comparable across groups. LPs performed with a J-Tip were twice as likely to be successful compared to those performed using TA (relative risk = 2.0; 95% confidence interval = 1.01-3.93; p = 0.04) with no difference in level of training or number of prior LPs performed by providers.

CONCLUSIONS

In a randomized controlled trial of two modalities for local anesthesia in infant LPs, J-Tip was not superior to TA cream as measured by pain control or physiologic changes. Infant LPs performed with J-Tip were twice as likely to be successful.

摘要

目的

腰椎穿刺(LP)常用于发热婴儿以评估脑膜炎,局部麻醉可提高 LP 成功率。传统的局部麻醉方法需要注射,可能会引起疼痛,或者使用局部麻醉剂,效果不能立即显现。最近无针射流注射的进步可能为这些方法提供了一种快速替代方法。我们比较了一种无针射流注射系统(J-Tip)与 1%缓冲利多卡因和局部麻醉剂(TA)乳膏在婴儿 LP 中的局部麻醉效果。

方法

这是一项在城市三级保健儿童医院急诊科进行的 J-Tip 与 TA 用于婴儿 LP 的单中心随机双盲试验。采用计算机随机模型对患者进行分组。0 至 4 个月大的患者被随机分配到含有 1%利多卡因的 J-Tip 注射器和安慰剂 TA 乳膏或含有生理盐水和 TA 的 J-Tip 注射器。主要结局是在 LP 针插入之前和期间新生儿面部编码量表(NFCS)之间的差异。次要结局包括整个过程中心率(HR)和 NFCS 的变化、LP 难度、LP 尝试次数、提供者对疼痛控制的印象、额外使用利多卡因、LP 部位皮肤变化以及 LP 成功率。

结果

我们共纳入 66 名受试者;32 名被随机分配到 J-Tip 利多卡因组,34 名被分配到 EMLA 组。由于年龄大于 4 个月,有 6 名参与者被排除在最终分析之外,其余 58 名参与者按照各自的组别进行分析(32 名 J-Tip,34 名 TA)。在 LP 前和针插入期间,两组 NFCS 无差异(p=0.58,p=0.37)。整个过程中,HR 和 NFCS 在组间无差异。提供者对疼痛控制的感知和对额外利多卡因的需求在组间相当。与使用 TA 相比,使用 J-Tip 进行的 LP 成功率高两倍(相对风险=2.0;95%置信区间=1.01-3.93;p=0.04),但提供者的培训水平或之前 LP 的数量没有差异。

结论

在一项比较两种 LP 局部麻醉方法的随机对照试验中,J-Tip 在疼痛控制或生理变化方面并不优于 TA 乳膏。使用 J-Tip 进行的 LP 成功率高两倍。

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