【原】【罂粟摘要】术前经鼻使用右美托咪定或咪达唑仑对扁桃体切除术和腺样体切除术中儿童呼吸不良事件发生的影响:一项随机临床试验

经鼻术前使用右美托咪定或咪达唑仑对扁桃体切除术和腺样体切除术中儿童呼吸不良事件发生的影响:一项随机临床试验

贵州医科大学 麻醉与心脏电生理课题组

翻译：柏雪   编辑：柏雪   审校：曹莹

背景：围手术期呼吸不良事件(PRAEs)是小儿麻醉中最常见的并发症，它们可能受到术前镇静剂的影响。

目的：探讨术前经鼻使用右美托咪定或咪达唑仑对PRAEs发生的影响。

设计、设置和参与者：这项单中心、双盲、随机临床试验于2020年10月至2021年6月收集了在中国徐州医科大学儿童医院进行了择期扁桃体切除术和腺样体切除术的0至12岁儿童病例。数据分析时间为2021年6月至10月。

干预措施：将患儿随机分为3组:咪达唑仑组术前给予经鼻使用咪达唑仑 (0.1 mg/kg)；右美托咪定组术前给予经鼻使用右美托咪定（2.0 μg/kg)；对照组术前给予经鼻使用0.9%生理盐水。

主要结局和测量：主要结局为三组间PRAEs发生率的差异。次要结局是个体PRAEs的频率，包括诱导和恢复期此类事件的发生率、术后出现谵妄、术后疼痛评分、镇静成功率和心率值。

结果：共384例患儿(中位[IQR]年龄为7[5-10]岁;227名男孩[59.1%])被纳入并随机分组;373组数据可用于意向治疗分析(咪达唑仑组124例，右美托咪定组124例，生理盐水组125例)。在校正了年龄、性别、美国麻醉医师协会身体状况、体重指数、阻塞性睡眠呼吸暂停、上呼吸道感染和被动吸烟等因素后，咪达唑仑组儿童发生PRAEs的可能性高于生理盐水组(124名儿童中有70名[56.5%]vs 125名儿童中有51名[40.8%];校正优势比[aOR]，1.99;95% CI, 1.18-3.35)，而右美托咪定组PRAEs发生率显著低于生理盐水组(124例患儿中30例[24.2%]vs 125例患儿中51例[40.8%];优势比,0.45;95% CI, 0.26-0.78)。与右美托咪定组相比，咪达唑仑组PRAEs发生风险更高(aOR, 4.44;95% CI, 2.54-7.76)，但未观察到其他严重的临床不良事件。

结论和相关性: 在这项随机临床试验中，术前经鼻使用咪达唑仑与PRAEs发生率增加相关，而术前经鼻使用右美托咪定与PRAEs发生率降低相关。在临床上适当的情况下，麻醉医师应考虑在接受扁桃体切除术和腺样体切除术的儿童中使用经鼻右美托咪定镇静。

原始文献来源：Fangming Shen, Qin Zhang, Yahui Xu, et, al. Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy A Randomized Clinical Trial. JAMA Network Open. 2022;5(8):e2225473. doi:10.1001/jamanetworkopen.2022.25473

英文原文：

Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy A Randomized Clinical Trial

IMPORTANCE Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia, and they may be affected by the administration of preoperative sedatives.

OBJECTIVE To investigate the effect of intranasal dexmedetomidine or midazolam used for premedication on the occurrence of PRAEs.

DESIGN, SETTING, AND PARTICIPANTS This single-center, double-blind, randomized clinical trial was conducted among children aged 0 to 12 years undergoing elective tonsillectomy and adenoidectomy from October 2020 to June 2021 at Children’s Hospital of Xuzhou Medical University, Xuzhou, China. Data analysis was performed from June to October 2021.

INTERVENTIONS Children were randomly assigned to 3 groups: the midazolam group received intranasal midazolam (0.1 mg/kg), and the dexmedetomidine group received intranasal dexmedetomidine (2.0 μg/kg) for premedication. The normal saline group received intranasal 0.9% saline for control.

MAIN OUTCOMES AND MEASURES The primary outcome was the difference in the incidence of PRAEs among the 3 groups. The secondary outcomes were the frequency of the individual PRAEs, including the incidence of such events during the induction and recovery periods, postoperative emergence delirium, postoperative pain score, sedation success rate, and heart rate values.

RESULTS A total of 384 children (median [IQR] age, 7 [5-10] years; 227 boys [59.1%]) were enrolled and randomized; 373 data sets were available for intention-to-treat analysis (124 children in the midazolam group, 124 children in the dexmedetomidine group, and 125 children in the normal saline group). After the data were adjusted for age, sex, American Society of Anesthesiologists physical status, body mass index, obstructive sleep apnea, upper respiratory tract infection, and passive smoking, children in the midazolam group were more likely to experience PRAEs than those in the normal saline group (70 of 124 children [56.5%] vs 51 of 125 children [40.8%]; adjusted odds ratio [aOR], 1.99; 95% CI, 1.18-3.35), whereas the dexmedetomidine group had a significantly lower PRAEs incidence than the normal saline group (30 of 124 children [24.2%] vs 51 of 125 children [40.8%]; aOR, 0.45; 95% CI, 0.26-0.78). Compared with the dexmedetomidine group, the midazolam group had a higher risk of PRAEs (aOR, 4.44; 95% CI, 2.54-7.76), but no other serious clinical adverse events were observed.

CONCLUSIONS AND RELEVANCE In this randomized clinical trial, intranasal midazolam used for premedication was associated with increased incidence of PRAEs, whereas premedication with intranasal dexmedetomidine was associated with reduced incidence of PRAEs. Where clinically appropriate, anesthesiologists should consider using intranasal dexmedetomidine for sedation in children undergoing tonsillectomy and adenoidectomy.

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