托洛沙酮贴剂与安慰剂对扁桃体切除术患儿发生呼吸系统不良事件的影响：一项随机对照试验。

Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: A Randomized Controlled Trial.

机构信息

From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.

Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

出版信息

Anesth Analg. 2023 Jun 1;136(6):1067-1074. doi: 10.1213/ANE.0000000000006355. Epub 2023 May 19.

DOI:10.1213/ANE.0000000000006355

PMID:36727868

Abstract

BACKGROUND

Perioperative respiratory adverse events are common in children. We aimed to evaluate the effect of the transdermal β-2 agonist, tulobuterol, compared with that of placebo on the incidence of perioperative respiratory adverse events in pediatric patients undergoing tonsillectomy.

METHODS

In this triple-blinded (patient, anesthesia provider, and outcome assessor) randomized controlled trial, 188 patients were randomly allocated to receive tulobuterol or a placebo. The tulobuterol groups received a tulobuterol patch (1 mg) masked with a bandage, whereas the placebo only received the bandage. The assigned bandage was applied to the patients 8 to 10 hours before the surgery. The primary outcome was the occurrence of any perioperative respiratory adverse events: oxygen desaturation <95%, airway obstruction, laryngospasm, bronchospasm, severe coughing, or stridor. The outcomes were evaluated using the average relative effect test, which estimates the effect of individual components of a composite outcome and then averages effects across components.

RESULTS

A total of 88 and 94 patients who received tulobuterol and placebo, respectively, were analyzed. The incidence of any perioperative respiratory adverse event was lower with tulobuterol (n = 13/88; 14.7%) than that with the placebo (n = 40/94; 42.5%), with an estimated average relative risk (95% confidence interval) across components of 0.35 (0.20-0.60; P < .001). The symptoms of airway obstruction were lower with tulobuterol (n = 8/88; 9.0%) than that with the placebo (n = 32/94; 34.0%), with relative risk (95% CI) of 0.31 (0.17-0.56; P < .001). The occurrence of severe coughing was lower with tulobuterol (n = 1/88; 1.1%) than that with the placebo (n = 8/94; 8.5%), with relative risk (95% CI) of 0.15 (0.03-0.68; P = .014).

CONCLUSIONS

In preschool children undergoing tonsillectomy, the preoperative application of a tulobuterol patch could decrease the occurrence of perioperative respiratory adverse events. Further studies are needed to elucidate the effect of the tulobuterol patch in a broad spectrum of pediatric anesthesia.

摘要

背景

围手术期呼吸不良事件在儿童中很常见。我们旨在评估透皮β-2 激动剂妥洛特罗与安慰剂相比，在接受扁桃体切除术的儿科患者中对围手术期呼吸不良事件发生率的影响。

方法

在这项三盲（患者、麻醉提供者和结果评估者）随机对照试验中，188 名患者被随机分配接受妥洛特罗或安慰剂。妥洛特罗组接受妥洛特罗贴剂（1 毫克），并用绷带覆盖，而安慰剂组仅使用绷带。手术前 8 至 10 小时，将分配的绷带贴在患者身上。主要结局是发生任何围手术期呼吸不良事件：氧饱和度<95%、气道阻塞、喉痉挛、支气管痉挛、剧烈咳嗽或喘鸣。使用平均相对效应检验评估结果，该检验估计复合结局各个组成部分的效果，然后对各组成部分的效果进行平均。

结果

分别接受妥洛特罗和安慰剂的 88 名和 94 名患者进行了分析。妥洛特罗组（n = 13/88；14.7%）的任何围手术期呼吸不良事件发生率低于安慰剂组（n = 40/94；42.5%），各组成部分的估计平均相对风险（95%置信区间）为 0.35（0.20-0.60；P<.001）。妥洛特罗组（n = 8/88；9.0%）的气道阻塞症状发生率低于安慰剂组（n = 32/94；34.0%），相对风险（95%CI）为 0.31（0.17-0.56；P<.001）。妥洛特罗组（n = 1/88；1.1%）严重咳嗽的发生率低于安慰剂组（n = 8/94；8.5%），相对风险（95%CI）为 0.15（0.03-0.68；P =.014）。