Chan Esther W, Lao Kim S J, Lam Lam, Tsui Sik-Hon, Lui Chun-Tat, Wong Chi-Pang, Graham Colin A, Cheng Chi-Hung, Chung Tong-Shun, Lam Hiu-Fung, Ting Soo-Moi, Knott Jonathan C, Taylor David M, Kong David C M, Leung Ling-Pong, Wong Ian C K
Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, The University of Hong Kong, Hong Kong SAR.
Department of Pharmacy, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.
EClinicalMedicine. 2021 Feb 11;32:100751. doi: 10.1016/j.eclinm.2021.100751. eCollection 2021 Feb.
The safety and effectiveness of intramuscular olanzapine or haloperidol compared to midazolam as the initial pharmacological treatment for acute agitation in emergency departments (EDs) has not been evaluated.
A pragmatic, randomised, double-blind, active-controlled trial was conducted from December 2014 to September 2019, in six Hong Kong EDs. Patients (aged 18-75 years) with undifferentiated acute agitation requiring parenteral sedation were randomised to 5 mg intramuscular midazolam ( = 56), olanzapine ( = 54), or haloperidol ( = 57). Primary outcomes were time to adequate sedation and proportion of patients who achieved adequate sedation at each follow-up interval. Sedation levels were measured on a 6-level validated scale (ClinicalTrials.gov Identifier: NCT02380118).
Of 206 patients randomised, 167 (mean age, 42 years; 98 [58·7%] male) were analysed. Median time to sedation for IM midazolam, olanzapine, and haloperidol was 8·5 (IQR 8·0), 11·5 (IQR 30·0), and 23·0 (IQR 21·0) min, respectively. At 60 min, similar proportions of patients were adequately sedated (98%, 87%, and 97%). There were statistically significant differences for time to sedation with midazolam compared to olanzapine ( = 0·03) and haloperidol ( = 0·002). Adverse event rates were similar across the three arms. Dystonia ( = 1) and cardiac arrest ( = 1) were reported in the haloperidol group.
Midazolam resulted in faster sedation in patients with undifferentiated agitation in the emergency setting compared to olanzapine and haloperidol. Midazolam and olanzapine are preferred over haloperidol's slower time to sedation and potential for cardiovascular and extrapyramidal side effects.
Research Grants Council, Hong Kong.
与咪达唑仑相比，肌内注射奥氮平或氟哌啶醇作为急诊科急性躁动初始药物治疗的安全性和有效性尚未得到评估。
2014年12月至2019年9月，在香港的6家急诊科进行了一项实用、随机、双盲、活性对照试验。需要胃肠外镇静的未分化急性躁动患者（年龄18 - 75岁）被随机分为肌内注射5mg咪达唑仑组（n = 56）、奥氮平组（n = 54）或氟哌啶醇组（n = 57）。主要结局是达到充分镇静的时间以及在每个随访间隔达到充分镇静的患者比例。镇静水平采用6级有效量表进行测量（ClinicalTrials.gov标识符：NCT02380118）。
在随机分组的206例患者中，对167例（平均年龄42岁；98例[58.7%]为男性）进行了分析。肌内注射咪达唑仑、奥氮平和氟哌啶醇达到镇静的中位时间分别为8.5（四分位间距8.0）、11.5（四分位间距30.0）和23.0（四分位间距21.0）分钟。在60分钟时，达到充分镇静的患者比例相似（分别为98%、87%和97%）。与奥氮平（P = 0.03）和氟哌啶醇（P = 0.002）相比，咪达唑仑达到镇静的时间存在统计学显著差异。三组的不良事件发生率相似。氟哌啶醇组报告了1例肌张力障碍和1例心脏骤停。
在急诊环境中，与奥氮平和氟哌啶醇相比，咪达唑仑能使未分化躁动患者更快达到镇静。与氟哌啶醇相比，咪达唑仑和奥氮平更受青睐，因为氟哌啶醇达到镇静的时间较慢且有心血管和锥体外系副作用的风险。
香港研究资助局。
