Randomized Controlled Trial of Intramuscular Droperidol Versus Midazolam for Violence and Acute Behavioral Disturbance: The DORM Study
Randomized Controlled Trial of Intramuscular Droperidol Versus Midazolam for Violence and Acute Behavioral Disturbance: The DORM Study
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DOI：
10.1016/j.annemergmed.2010.05.037
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发表时间：
2010-10-01
影响因子：
6.2
通讯作者：
Downes, Michael A.
中科院分区：
文献类型：
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作者：
Isbister, Geoffrey K.;Calver, Leonie A.;Downes, Michael A.
研究目的：我们确定是否氟哌利多，咪达唑仑，或组合是更有效的肌肉镇静暴力和急性行为障碍在急诊科（艾德）。方法：我们进行了一项盲法随机对照试验肌肉镇静暴力和急性行为障碍，比较氟哌利多（10毫克），咪达唑仑（10毫克），氟哌利多（5毫克）/咪达唑仑（5毫克）。入选标准为需要身体约束和胃肠外镇静的患者。主要结果是暴力和急性行为障碍的持续时间，定义为需要保安人员的时间。次要结果包括时间，直到额外的镇静管理，工作人员和病人的伤害，进一步发作的暴力和急性行为障碍，药物相关的不良反应.Results：从223艾德暴力和急性行为障碍的患者，91例患者被纳入; 33氟哌利多，29咪达唑仑，29收到的组合。暴力和急性行为障碍的中位持续时间无差异：氟哌利多组为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），联合用药组为25分钟（IQR 15至38分钟）。氟哌利多组11例（33%; 95%置信区间[CI] 19%-52%）、咪达唑仑组18例（62%; 95% CI 42%-79%）和联合用药组12例（41%; 95% CI 24%-61%）患者需要额外镇静。咪达唑仑与氟哌利多组额外镇静的风险比为2.31（95%可信区间1.01至4.71）;联合用药与氟哌利多组为1.18（95%可信区间0.46至2.50）。患者和工作人员的伤害和暴力和急性行为障碍的进一步发作的数量在两组之间没有差异。氟哌利多组有2例不良反应（6%; 95% CI 1%-22%），咪达唑仑组有8例不良反应（28%; 95% CI 13%-47%），联合用药组有2例不良反应（7%; 95% CI 1%-24%）。一个异常的QT发生在2 31（6%; 95%CI 1%至23%）氟哌利多患者，这是没有从其他groups.Conclusion不同：肌内氟哌利多和咪达唑仑导致类似的暴力和急性行为障碍的持续时间，但更多的额外镇静需要咪达唑仑。咪达唑仑因过度镇静而引起更多不良反应，与咪达唑仑相比，没有证据表明氟哌利多与QT间期延长相关。[Ann 2010;56：392-401.]
Study objective: 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).Methods: 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.Results: 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.Conclusion: 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. [Ann Emerg Med. 2010;56:392-401.]