Department of Clinical Toxicology and Pharmacology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
Ann Emerg Med. 2010 Oct;56(4):392-401.e1. doi: 10.1016/j.annemergmed.2010.05.037.
We determine whether droperidol, midazolam, or the combination is more effective for intramuscular sedation in violent and acute behavioral disturbance in the emergency department (ED).
We conducted a blinded randomized controlled trial of intramuscular sedation for violent and acute behavioral disturbance, comparing droperidol (10 mg), midazolam (10 mg), and droperidol (5 mg)/midazolam (5 mg). Inclusion criteria were patients requiring physical restraint and parenteral sedation. The primary outcome was the duration of the violent and acute behavioral disturbance, defined as the time security staff were required. Secondary outcomes included time until additional sedation was administered, staff and patient injuries, further episodes of violent and acute behavioral disturbance, and drug-related adverse effects.
From 223 ED patients with violent and acute behavioral disturbance, 91 patients were included; 33 received droperidol, 29 received midazolam, and 29 received the combination. There was no difference in the median duration of the violent and acute behavioral disturbance: 20 minutes (interquartile range [IQR] 11 to 37 min) for droperidol, 24 minutes (IQR 13 to 35 minutes) for midazolam, and 25 minutes (IQR 15 to 38 minutes) for the combination. Additional sedation was required in 11 (33%; 95% confidence interval [CI] 19% to 52%) droperidol patients, 18 (62%; 95% CI 42% to 79%) midazolam patients, and 12 (41%; 95% CI 24% to 61%) in the combination group. The hazard ratio for additional sedation in the midazolam versus droperidol group was 2.31 (95% credible interval 1.01 to 4.71); for the combination versus droperidol, 1.18 (95% credible interval 0.46 to 2.50). Patient and staff injuries and number of further episodes of violent and acute behavioral disturbance did not differ between groups. There were two adverse effects for droperidol (6%; 95% CI 1% to 22%), 8 for midazolam (28%; 95% CI 13% to 47%), and 2 for the combination (7%; 95% CI 1% to 24%). An abnormal QT occurred in 2 of 31 (6%; 95% CI 1% to 23%) droperidol patients, which was not different from the other groups.
Intramuscular droperidol and midazolam resulted in a similar duration of violent and acute behavioral disturbance, but more additional sedation was required with midazolam. Midazolam caused more adverse effects because of oversedation, and there was no evidence of QT prolongation associated with droperidol compared with midazolam.
我们旨在确定在急诊科（ED）中，对于暴力和急性行为障碍，哪种药物（氟哌啶醇、咪达唑仑或两者联合）的肌内镇静效果更佳。
我们进行了一项肌内镇静治疗暴力和急性行为障碍的双盲随机对照试验，比较了氟哌啶醇（10mg）、咪达唑仑（10mg）和氟哌啶醇（5mg）/咪达唑仑（5mg）。纳入标准为需要身体约束和静脉内镇静的患者。主要结局为暴力和急性行为障碍的持续时间，定义为安保人员需要干预的时间。次要结局包括给予额外镇静所需的时间、医护人员和患者受伤情况、进一步出现的暴力和急性行为障碍、以及药物相关不良反应。
在 223 名出现暴力和急性行为障碍的 ED 患者中，有 91 名患者入组，其中 33 名接受氟哌啶醇治疗，29 名接受咪达唑仑治疗，29 名接受联合治疗。暴力和急性行为障碍的持续时间中位数无差异：氟哌啶醇组为 20 分钟（四分位距[IQR]11 至 37 分钟），咪达唑仑组为 24 分钟（IQR 13 至 35 分钟），联合组为 25 分钟（IQR 15 至 38 分钟）。氟哌啶醇组需要额外镇静的患者有 11 名（33%；95%置信区间[CI]19%至 52%），咪达唑仑组有 18 名（62%；95% CI 42%至 79%），联合组有 12 名（41%；95% CI 24%至 61%）。咪达唑仑与氟哌啶醇组相比，需要额外镇静的风险比为 2.31（95%可信区间 1.01 至 4.71）；联合与氟哌啶醇组相比，风险比为 1.18（95%可信区间 0.46 至 2.50）。患者和医护人员受伤情况以及进一步出现的暴力和急性行为障碍次数在各组间无差异。氟哌啶醇组有 2 例（6%；95% CI 1%至 22%）发生不良反应，咪达唑仑组有 8 例（28%；95% CI 13%至 47%），联合组有 2 例（7%；95% CI 1%至 24%）。氟哌啶醇组有 2 例（6%；95% CI 1%至 23%）出现 QT 间期异常，与其他组无差异。
肌内氟哌啶醇和咪达唑仑均可导致相似时间的暴力和急性行为障碍，但咪达唑仑组需要更多的额外镇静。咪达唑仑引起更多的不良反应是由于过度镇静，与咪达唑仑相比，氟哌啶醇并未导致 QT 间期延长。
