Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, University of Hong Kong.
Ann Emerg Med. 2013 Jan;61(1):72-81. doi: 10.1016/j.annemergmed.2012.07.118. Epub 2012 Sep 13.
Parenteral benzodiazepines or antipsychotics are often used to manage acute agitation in emergency department (ED) settings in which alternative strategies have failed or are not feasible. There are scant data comparing parenteral medication regimens. We aim to determine the efficacy and safety of intravenous droperidol or olanzapine as an adjunct to intravenous midazolam for rapid patient sedation.
We undertook a randomized, double-blind, placebo-controlled, double-dummy, clinical trial in 3 EDs (August 2009 to March 2011). Adult patients (n=336) requiring intravenous drug sedation for acute agitation were randomized to receive a saline solution (control), droperidol (5 mg), or olanzapine (5 mg) bolus. This was immediately followed by incremental intravenous midazolam boluses (2.5 to 5 mg) until sedation was achieved. The primary outcome was time to sedation. Secondary outcomes were need for "rescue" drugs and adverse events.
Three hundred thirty-six patients were randomized to the 3 groups. Baseline characteristics were similar across groups. The differences in medians for times to sedation between the control and droperidol and control and olanzapine groups were 4 minutes (95% confidence interval [CI] 1 to 6 minutes) and 5 minutes (95% CI 1 to 6 minutes), respectively. At any point, patients in the droperidol and olanzapine groups were approximately 1.6 times more likely to be sedated compared with controls: droperidol and olanzapine group hazard ratios were 1.61 (95% CI 1.23 to 2.11) and 1.66 (95% CI 1.27 to 2.17), respectively. Patients in the droperidol and olanzapine groups required less rescue or alternative drug use after initial sedation. The 3 groups' adverse event profiles and lengths of stay did not differ.
Intravenous droperidol or olanzapine as an adjunct to midazolam is effective and decreases the time to adequate sedation compared with midazolam alone.
在替代策略失败或不可行的急诊（ED）环境中，常使用肠外苯二氮䓬类药物或抗精神病药来控制急性激越。比较肠外药物治疗方案的数据很少。我们旨在确定静脉注射氟哌啶醇或奥氮平作为静脉注射咪达唑仑辅助治疗快速患者镇静的疗效和安全性。
我们在 3 家急诊室（2009 年 8 月至 2011 年 3 月）进行了一项随机、双盲、安慰剂对照、双模拟、临床试验。需要静脉药物镇静治疗急性激越的成年患者（n=336）被随机分为接受生理盐水（对照）、氟哌啶醇（5mg）或奥氮平（5mg）推注。这立即随后是递增的静脉注射咪达唑仑推注（2.5 至 5mg），直到达到镇静状态。主要结局是镇静时间。次要结局是需要“抢救”药物和不良事件。
336 名患者被随机分为 3 组。各组的基线特征相似。对照组与氟哌啶醇组和对照组与奥氮平组之间的镇静时间中位数差异分别为 4 分钟（95%置信区间[CI] 1 至 6 分钟）和 5 分钟（95%CI 1 至 6 分钟）。在任何时候，与对照组相比，氟哌啶醇和奥氮平组的患者镇静的可能性大约高 1.6 倍：氟哌啶醇和奥氮平组的风险比分别为 1.61（95%CI 1.23 至 2.11）和 1.66（95%CI 1.27 至 2.17）。初始镇静后，氟哌啶醇和奥氮平组患者需要的抢救或替代药物使用较少。三组的不良事件谱和住院时间没有差异。
与单独使用咪达唑仑相比，氟哌啶醇或奥氮平作为咪达唑仑的辅助治疗可有效且缩短达到充分镇静的时间。
