Ketamine Versus Midazolam for Prehospital Agitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Time from injection of drug to adequate sedation, defined as a score of +1 or less on the AMSS
研究概览
简要总结
This research study is being done to figure out the best approach to treatment of pre-hospital agitation. It will compare two tiered dosing treatment protocols, one ketamine-based and one midazolam-based. 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 are 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 a ketamine-based protocol will achieve a faster time to adequate sedation than a midazolam-based protocol for treatment of agitation in the prehospital environment. This study will observe the natural history of an emergency medical services standard operating procedure change from a ketamine-based protocol to a midazolam-based protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 or older
- •Severe agitation (AMSS +2 or +3) or profound agitation (AMSS +4) requiring chemical sedation
- •Transport to Hennepin County Medical Center
排除标准
- •Obviously gravid women
- •Patients known or suspected to be less than 18 years of age
- •Patients in which stopwatch activation, for safety reasons, is unable to occur
结局指标
主要结局
Time from injection of drug to adequate sedation, defined as a score of +1 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 AMSS score less than or equal to +1. 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 participants intubated(2 hours)
- Number of participants experiencing hypersalivation(2 hours)
- Number of participants experiencing apnea(2 hours)
- Number of participants needing rescue sedation(2 hours)
- Number of participants experiencing nausea/vomiting(2 hours)
- Number of participants experiencing laryngospasm(2 hours)