TREC-Lebanon Trial: A Randomised Controlled Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil
研究概览
简要总结
This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.
详细描述
This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department. Around 10% of patients will present to the psychiatric emergency unit with a violent episode that requires rapid tranquilisation. Surveys of practice and opinion has shown that variety of methods have been used and no universal option exists. This study will look at Haloperidol plus promethazine versus haloperidol plus promethazine plus chlorpromazine in violent aggressive psychiatric patients.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient will be eligible if (1) requiring emergency acute intramuscular sedation because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of the benefits between haloperidol plus promethazine vs haloperidol plus promethazine plus chlorpromazine.
- •Gender - both male and female
- •Age (18-64)
- •Clinician is unaware on the effects of either treatment interventions
排除标准
- •If the clinician KNOWS one treatment has benefit over another for a particular person
- •If the clinician is aware of a contra-indication of one of the treatments
- •If there is an Advanced Directive expressing a wish for one or other, or another treatment in the emergency setting.
- •If the clinician does not want to undertake for both personal and professional reasons.
- •If the participant is known to be allergic to one or more of the interventions
- •Already randomized
- •Already sedated
- •Accompanying person (Friend/Family/Police Officer) refuses patient trial entry
研究组 & 干预措施
Haloperidol + Promethazine + Chlorpromazine
Haloperidol + Promethazine + Chlorpromazine are all psychiatric drugs that have been well tested. The combination of these 3 drugs, however, have never been randomised.
干预措施: Haloperidol + Promethazine + Chlorpromazine (Drug)
Haloperidol + Promethazine
Haloperidol + Promethazine are both psychiatric drugs with antipsychotic and calming properties.
干预措施: Haloperidol + Promethazine (Drug)
结局指标
主要结局
Number of Participants According to the Time Taken for Aggressive Behaviour to Change to Calm and Tranquil
时间窗: 20, 40, 60 and 120 minutes post intervention treatment
Patient no longer exhibiting aggressive behavior both verbal and physical post intervention treatment. A primary measure of outcome form will contain a Calm or Tranquil column followed by four rows: 20 mins, 40 mins, 60 mins and 120 mins post intervention medication. The boxes would be ticked depending if the patient meets the primary measure of outcome within the time frame provided.
次要结局
- Time Taken for Patient to Fall Asleep Post Intervention(20, 40, 60 and 120 minutes post intervention treatment)
- Time Patient Was Placed in Straitjacket/Restraint Post Intervention Treatment(20, 40, 60 and 120 minutes post intervention treatment)
- Time Noted Where Important Adverse Effects Occurred Post Intervention(20, 40, 60 and 120 minutes post intervention treatment)
- Time Patient Left the Ward Against Medical Advice During the Time Period After the Intervention Was Administered.(20, 40, 60 and 120 minutes post intervention treatment)
研究者
Joseph Dib
Director of Trial Research
Hopital Psychiatrique De La Croix