Rapid Tranquilization of Violent or Agitated People in Psychiatric Emergency Settings- A Pragmatic Randomized Controlled Trial of Intramuscular Olanzepine Vs. Intramuscular Haloperidol + Promethazine.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Number of participants tranquil or alseep at four hours after the intevention
研究概览
简要总结
Three hundred consecutive adult patients presenting to the emergency services of the department of psychiatry and who are diagnosed by the treating doctor to be needing tranquillization to control agitated or aggressive behavior will be randomized to receive either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50 mg in this parallel group, block randomized, centrally-randomzed, allocation-concealed, assessor-blinded pragmatic clinical trial.
The main outcome measure that the two treatments would be compared on would be the clinical state of the patient 4 hours after intervention, but the rate of tranquillization, degree of sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for additional medication, use of physical restraints, doctors called back, numbers absconding and adverse effects at each of these time points would also be compared. Compliance with oral medication and adverse effects at the end of 2 weeks would also be compared.
详细描述
Participants:
Consecutive adult psychiatric patients presenting to the department of psychiatry as outpatients, or those who are admitted, who have violent, aggressive or agitated behavior.
Inclusion criteria
- The attending physician feels that intramuscular sedation is clearly indicated because of agitation, aggression or violent behaviour, and
- The physician does not feel that either one of the interventions poses an additional risk for the patient.
- The patient or a responsible relative provides informed consent to participate in the trial.
Exclusion Criteria
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
- Single
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person with a major mental disorder needs acute intramuscular sedation because of disturbed and dangerous behavior as decided by the attending physician.
排除标准
- •The clinician believes that one of the two treatments represents an additional risk for the patient and/or
- •Patients who lack capacity to give informed consent and who do not have a relative to obtain consent.
结局指标
主要结局
Number of participants tranquil or alseep at four hours after the intevention
次要结局
- Number of participants tranquil or asleep at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
- Number of participants in restraints at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
- Number of participants who had absconded at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
- Number of participants who recived additional medication at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
- Number of participants for whom the doctor was called back at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
- Mean time till tranquillization
- Mean time till asleep
- Proportions improved on Clinical Global Impression scale at ech time pointof follow up
- Mean change on CGI scores at each time pint of follow up
- Adverse effects reported/observed
- Scores on Simpson-Angus extrapyramidal rating scale
- Scores on Barnes Akathisia Rating Scale