Intramuscular Olanzapine Versus Haloperidol or Midazolam for the Management of Acute Agitation in the Emergency Department - a Multicentre Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 6
- 主要终点
- Time to achieve adequate sedation
研究概览
简要总结
The purpose of this study is to determine whether intramuscular olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or midazolam when used in the management of acute agitation in the emergency department.
详细描述
To address significant knowledge gaps by several means:
- Investigate intramuscular use of sedative drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.
The multi-centre RCT will determine the safety and efficacy of intramuscular olanzapine, in comparison with conventional medicines (haloperidol or midazolam) in a three-arm comparison for the sedation of acutely agitated patients in emergency department. Specifically, we aim to determine if administration of intramuscular olanzapine (a)is more effective than sedation with intramuscular haloperidol or intramuscular midazolam alone; (b)is safer than sedation with comparison arms; (c)decreases the amount of subsequent redosing or alternative drugs required; (d)is more favourable than the haloperidol and midazolam arms with respect to safety, efficacy and adverse events. 2. Investigate potential variables leading to emergency attendance and/or admission requiring parenteral sedation. These may include patient demographics and regular medications and adherence.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency Department patients, requiring parenteral drug sedation (as determined by an emergency clinician) will be enrolled.
排除标准
- •Patients will be excluded if there are
- •known hypersensitivity or contraindication to the study drugs
- •reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
- •known pregnancy
- •acute alcohol withdrawal
- •patients aged>75 years.
研究组 & 干预措施
Olanzapine
intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose.
干预措施: Olanzapine (Drug)
Haloperidol
intramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose.
干预措施: Haloperidol (Drug)
Midazolam
intramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose.
干预措施: Midazolam (Drug)
结局指标
主要结局
Time to achieve adequate sedation
时间窗: Within 60 minutes from drug administration
Adequate sedation is determined by a 6-point validated scale.
次要结局
- AED length of stay (LOS)(From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour)
- Total study drug doses administered; alternative drugs and doses used(From Emergency Department admission to transfer or discharge from AED, an expected average of 1 hour)
- Prolonged QTc interval(From Emergency Department admission to transfer or discharge from Emergency Department, an expected average of 1 hour)
- Adverse events(From Emergency Department admission to transfer or discharge from Emergency Department an expected average of 1 hour)
研究者
Dr. Esther Wai Yin Chan
Associate Professor
The University of Hong Kong