【原】[罂粟摘要]自闭症谱系障碍患者麻醉前口服咪达唑仑与氯胺酮联合咪达唑仑的比较：一项双盲随机临床试验

自闭症谱系障碍患者麻醉前口服咪达唑仑与氯胺酮联合咪达唑仑的比较：一项双盲随机临床试验

贵州医科大学       麻醉与心脏电生理课题组

翻译 : 文春雷     编辑 :  严旭    审校 :  曹莹

背景：自闭症谱系障碍（ASD）患者进行常规的口腔治疗是非常困难的。由于患者不配合，甚至有攻击行为，因此，需要给予这一类人群口腔治疗前用药。因此，本研究重点观察口服咪达唑仑与口服氯胺酮+咪达唑仑作为麻醉前药物治疗ASD的疗效。

方法：样本包括64名ASD患者，年龄在2-59岁，计划在全身麻醉下进行口腔治疗。本研究的主要目的是比较两个平行、双盲、同等比例组之间的镇静程度，分别随机接受口服咪达唑仑（0.5mg/kg，最大15 mg）或口服咪达唑仑（0.5mg/kg）+氯胺酮（3mg/kg，最大300 mg）。次要结局指标是无身体约束镇静下顺利建立静脉通道的发生率、苏醒时间和不良事件的发生率。

结果：根据镇静水平二分法分析（Ramsay评分分为1和2与Ramsay≥3），与单独口服咪达唑仑相比，口服咪达唑仑+氯胺酮改善了患者镇静程度，Ramsay≥3概率增加，相对风险（RR）= 3.2（95%可信区间[95%CI]=1.32-7.76）。联合治疗在无身体约束镇静下更容易建立静脉通路，RR=2.05（95%CI=1.14-3.68）。两组间苏醒时间与不良事件发生率无差异。

结论：口服氯胺酮与咪达唑仑的联合应用比单独使用咪达唑仑提供了更好的术前镇静率，并有助于自闭症患者的静脉注射。

原始文献来源：Penna HM,Paiva APM,Romano AJM,et al.Comparison between oral midazolam versus oral ketamine plus midazolam as preanesthetic medication in autism spectrum disorder: double-blind randomized clinical trial.[J].Braz J Anesthesiol,2023,73（3）:283–290.

英文原文:

Comparison between oral midazolam versus oral

ketamine plus midazolam as preanesthetic medication

in autism spectrum disorder: double-blind randomized

clinical trial

Background:Conventional dental care is often impossible in patients with Autism Spectrum Disorder (ASD). Non-collaborative behaviors, sometimes associated with aggressiveness, are usual justififications for premedication in this population. Thereby, this research focuses on the effects of oral midazolam versus oral ketamine plus midazolam as preanesthetic medication in ASD.

Methods: The sample included 64 persons with ASD, aged 2˗59 years, scheduled for dental care under general anesthesia. The primary objective of this study was to compare degrees of sedation between two parallel, double-blinded, equally proportional groups randomized to receiveoral midazolam (0.5 mg.kg-1, maximum 15 mg) or oral midazolam (0.5 mg.kg-1) associated with oral S(+)-ketamine (3 mg.kg-1,maximum 300 mg). The secondary outcomes were the need of physical stabilization to obtain intravenous line, awakening time, and occurrence of adverse events.

Results: According to the dichotomous analysis of sedation level (Ramsay score 1 and 2 versus Ramsay≥ 3), oral association of S(+)-ketamine and midazolam improved sedation, with increased probability of Ramsay≥ 3, Relative Risk (RR) = 3.2 (95% Confifidence Interval [95% CI] = 1.32 to 7.76) compared to midazolam alone. Combined treatment also made it easier to obtain venous access without physical stabilization, RR = 2.05 (95% CI = 1.14 to 3.68). There were no differences between groups regarding awakening time and the occurrence of adverse events.

Conclusion: The association of oral S(+)-ketamine with midazolam provides better preanesthetic sedation rates than midazolam alone and facilitates intravenous line access in patients with autism.