Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduction in the agitation score
研究概览
简要总结
This study aims to evaluate the efficacy and safety of four options of medications in the management of acute psychomotor agitation,or violence and aggression situations in health services. All of the treatment options are already approved and currently used for this purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine, olanzapine and ziprasidone. The investigators hypothesized that all treatment options are effective in the treatment of acute agitation, but the combination haloperidol plus promethazine could elicit more adverse affects than the others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients featuring psychomotor agitation, with clinical need for intramuscular injection
排除标准
- •delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options
研究组 & 干预措施
ziprasidone injection
ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation
干预措施: Ziprasidone (Drug)
haloperidol + midazolam, injection
Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation
干预措施: haloperidol + midazolam (Drug)
haloperidol + promethazine, injection
haloperidol + promethazine injection after baseline measures of agitation, could be repeated after 30 minutes, and once more, if necessary, in the 90 minutes period of observation
干预措施: haloperidol+promethazine (Drug)
olanzapine, injection
olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation
干预措施: olanzapine (Drug)
结局指标
主要结局
Reduction in the agitation score
时间窗: 90 minutes
Agitation scores were evaluated through two previously validated specific scales: ACES ( Agitation Calmness Evaluating Scale) and PANSS-EC ( Positive and Negative Symptoms Scale- Excited Component). The measure was collected by a blind rater at baseline and the subsequent measures aimed to evaluate the drug effect over agitation scores.
次要结局
- Adverse effects(12,24 hours after baseline)
研究者
Celia Mantovani
Principal investigator
University of Sao Paulo