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双盲、随机临床试验比较儿童中 1%缓冲与 2%未缓冲利多卡因注射。

Double-Blind, Randomized Clinical Trial Comparing One Percent Buffered Versus Two Percent Unbuffered Lidocaine Injections in Children.

机构信息

Dr. Baker is in private practice, North Carolina State University, Raleigh, N.C., USA.

Dr. Lee is a distinguished professor and chair, Division of Pediatric and Public Health, and a professor, Department of and Health Policy and Management, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, N.C., USA;, Email:

出版信息

Pediatr Dent. 2021 Mar 15;43(2):88-94.

PMID:33892831
Abstract

Buffered local anesthetics offer an alternative to conventional, unbuffered anesthetic formulations; however, evidence about their use in children is scant. The purpose of this study was to determine the anesthetic and physiologic differences associated with the use of buffered one percent and unbuffered two percent lidocaine (both with 1:100,000 epinephrine) in children. In this randomized, double-blinded, crossover study, 25 children ages 10 to 12 years old received two inferior alveolar never blocks, at least one week apart, randomized to alternating sequences of two drug formulations: (1) formula A-three mL buffered one percent lidocaine (i.e., including 0.3 mL of 8.4 percent sodium bicarbonate); or (2) formula B-three mL unbuffered two percent lidocaine. Primary outcomes were mean blood lidocaine levels (15 minutes post-injection), timing of clinical signs onset, response to pain on injection, and duration of anesthesia. Analyses relied upon analysis of variance for crossover study designs and a P<0.05 statistical significance criterion. The buffered formulation resulted in significantly lower mean blood lidocaine levels compared to unbuffered-a 63 percent (P<0.05) weight-adjusted relative decrease. The authors found no important differences in pain upon injection, onset, and duration of anesthesia. The buffered local anesthetic formulation showed equal effectiveness with a double-concentration unbuffered formulation while resulting in lower mean blood lidocaine levels-an important gain for the prevention of anesthetic toxicity.

摘要

缓冲局麻药为传统未缓冲局麻药制剂提供了替代方案;然而,关于其在儿童中应用的证据很少。本研究的目的是确定使用缓冲 1%和未缓冲 2%利多卡因(均含 1:100000 肾上腺素)在儿童中与麻醉和生理相关的差异。在这项随机、双盲、交叉研究中,25 名 10 至 12 岁的儿童接受了两次下牙槽神经阻滞,至少间隔一周,随机分为两种药物制剂的交替序列:(1)配方 A-3 毫升缓冲 1%利多卡因(即包括 0.3 毫升 8.4%碳酸氢钠);或(2)配方 B-3 毫升未缓冲 2%利多卡因。主要结局是平均血利多卡因水平(注射后 15 分钟)、临床体征出现时间、注射疼痛反应和麻醉持续时间。分析依赖于交叉研究设计的方差分析和 P<0.05 的统计显著性标准。与未缓冲相比,缓冲制剂导致平均血利多卡因水平显著降低-重量调整后的相对降低 63%(P<0.05)。作者发现注射疼痛、起效和麻醉持续时间没有重要差异。缓冲局麻药制剂与双浓度未缓冲制剂具有同等疗效,同时平均血利多卡因水平较低-这对于预防麻醉毒性是一个重要的收获。

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