Oro-dispersible Olanzapine (Wafer) Versus Conventional Oral Haloperidol or Diazepam Tablets for the Management of Acute Agitation in the Accident and Emergency Department - a Multicentre Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 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 oral olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or diazepam when used in the management of acute agitation in the emergency.
详细描述
- Investigate oral use of sedating drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.
- The multi-centre Randomised Clinical Trial will determine the safety and efficacy of oral olanzapine, in comparison with conventional medicines (haloperidol or diazepam) in a three-arm comparison for the sedation of acutely agitated patients in AEDs. Specifically, we aim to determine if administration of oral olanzapine (a)is more effective than sedation with oral haloperidol or oral diazepam 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 diazepam arms with respect to safety, efficacy and adverse events.
Investigate potential variables leading to AED attendance and/or admission requiring oral sedation. These may include patient demographic 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
- •Accident & Emergency Department patients
- •Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.
排除标准
- •known hypersensitivity or contraindication to the study drugs
- •reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
- •known pregnancy
- •acute alcohol withdrawal
- •refusal to take oral medication
- •patients from correctional facilities
研究组 & 干预措施
Olanzapine
oro-dispersible tablet (wafer)(Zyprexa), 5 mg, single dose
干预措施: Olanzapine oro-dispersible 5Mg Tab (Drug)
Haloperidol
Haloperidol encapsulated tablet, 2 mg tablet, single dose
干预措施: Haloperidol 2Mg encapsulated Tab (Drug)
Diazepam
Diazepam encapsulated tablet, 2mg tablet, single dose
干预措施: Diazepam 2Mg encapsulated Tab (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
- Total study drug doses administered; alternative drugs and doses used(From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour)
- Corrected QT interval (QTc)(From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour)
- AED length of stay (LOS)(From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour)
- Adverse events(From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour)
研究者
Dr. Esther Wai Yin Chan
Associate Professor
The University of Hong Kong