A Double Blinded Randomized Trial of Ketamine Versus Haloperidol for Severe Prehospital Agitation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS.
研究概览
简要总结
This research study is being done to find out if one of two drugs, ketamine or haloperidol, is better for treating agitation. Agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. Often chemical substances or severe mental illness is involved in this level of agitation. Specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. This study's hypothesis is that ketamine is superior to haloperidol for treatment of agitation in the prehospital environment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of severe agitation in the prehospital environment
排除标准
- •Prisoners
- •Persons known to be younger than 18 years old
- •Persons suspected to be younger than 18 years old
- •Obviously gravid women
- •Persons with profound agitation
- •Persons who are unable to be transported to the treating facility
研究组 & 干预措施
Ketamine
Patients enrolled in this arm will be given 500 mg of intramuscular ketamine for their severe agitation they experience in the prehospital environment.
干预措施: Ketamine (Drug)
Haloperidol
Patients enrolled in this arm will be given 10 mg of intramuscular haloperidol for their severe agitation they experience in the prehospital environment.
干预措施: Haloperidol (Drug)
结局指标
主要结局
Time from injection of drug to adequate sedation, defined as a score of 0 or less on the AMSS.
时间窗: 2 hours
The Altered Mental Status Scale (AMSS) is an integral ordinal scale evaluating both agitation and sedation with scores from -4 to +4. It was developed at our institution and has been internally and externally validated. This scale is a modified version of the Behavioral Activity Rating Scale with additional data points from the Observer's Assessment of Alertness Scale. Effectiveness of sedation will be defined as an AMS score less than or equal to 0. AMSS will be determined by the treating paramedic, who will undergo training as a research associate prior to commencement of the study. Participants will be followed for the duration of agitation, an expected average of 2 hours.
次要结局
- Number of patients admitted versus number of patients discharged.(2 hours)
- venous pH(at one minutes and ten minutes post sedation)
- Number of participants intubated.(2 hours)
- serum potassium(at one minute and ten minutes post sedation)
- Total time the participant is a patient in the Emergency Department.(2 hours)
- Number of patients experiencing laryngospasm.(2 hours)
- venous lactate(at one minute and ten minutes post sedation)
- Number of patients experiencing dystonia.(2 hours)