Rapid Agitation Control With Ketamine in the Emergency Department (RACKED): a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1.
研究概览
简要总结
Compare intramuscular (IM) ketamine to a combination of IM midazolam and haloperidol with regards to the time required for adequate behavioral control, in minutes, in patients presenting to the emergency department with psychomotor agitation and violent behavior.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 - 60 years inclusively;
- •Patients presenting to the emergency department with psychomotor agitation or violent behaviour (RASS score > +3).
排除标准
- •Less than 19 years of age;
- •Greater than 60 years of age;
- •Previous participation in this study;
- •Women suspected or known to be pregnant or breastfeeding;
- •Previous known hypersensitivity, intolerance or allergy to ketamine, midazolam or haloperidol or their components.
- •Subjects who are in comatose states or have CNS depression due to alcohol or are taking other depressant drugs.
- •Subjects with severe depressive states, spastic diseases and in Parkinson's syndrome, except in the case of dyskinesias due to levodopa treatment.
- •Senile patients with pre-existing Parkinson-like symptoms.
- •Subjects with a history of cerebrovascular accident
- •Subjects in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension
- •Subjects with severe cardiac decompensation
- •Subjects who intend to have surgery of the pharynx, larynx, or bronchial tree unless adequate muscle relaxants are used
- •Subjects with acute pulmonary insufficiency
- •Subjects with severe chronic obstructive pulmonary disease
- •Subjects with acute narrow angle glaucoma
研究组 & 干预措施
Ketamine
Single administration of Ketalar® (ketamine hydrochloride injection, USP); 5 mg/kg, IM
干预措施: Ketalar (Drug)
Midazolam + haloperidol
Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM)
干预措施: Midazolam injection (Drug)
Midazolam + haloperidol
Single administration of combination of: Midazolam injection (5 mg, IM) and haloperidol injection (5mg, IM)
干预措施: Haloperidol (Drug)
结局指标
主要结局
Time from first IM medication administration to adequate sedation which is defined as RASS less than or equal to -1.
时间窗: 1 day
Measured using Richmond Agitation Sedation Scale (RASS) in each arm
次要结局
- Participant experience survey outcomes.(1 day)
- Study Nurse Experience survey outcomes.(1 day)
- Percentage participants with adverse events in each arm(up to 4 days)
- Effectiveness of Blinding survey outcomes(1 day)
- Percentage of participants in each arm requiring rescue medications between 5 and 30 minutes (at 5 minutes interval) after study medication(s) administration by count.(1 day)
- Percentage of participants with neuroleptic malignant syndrome events within 24 hours of enrollment of each arm.(1 day)
- Percentage of participants in each arm experiencing sedation outcomes as defined by the TROOPS criteria(1 day)
- Percentage of participants experiencing pre-hospital use of force by police in this participant population, by number and type of restraint.(1 day)
研究者
David Barbic
Clinical Assistant Professor
University of British Columbia