Prospective Observational Investigation of Olanzapine Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Proportion of Patients Adequately Sedated at 15 minutes
研究概览
简要总结
The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.
详细描述
The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.
In the summer of 2017, the ED implemented a treatment protocol as a quality improvement initiative. The investigators performed observational research on this protocol and identified that haloperidol and ziprasidone were inferior to midazolam and olanzapine for treating agitation in our Department.
The comparison between olanzapine and midazolam, however, was inconclusive. It is possible that this is due to inadequate power, so the question of whether olanzapine or midazolam is superior is still unknown.
Because the department continues to strive to achieve the best care for this patient population, in the Summer of 2018 the ED is going to initiate a second ED treatment protocol of olanzapine and midazolam, based on the results of our 2017 protocol.
All patients requiring chemical sedation for will receive olanzapine as the initial treatment for agitation for 6 weeks, followed by midazolam as the initial treatment for agitation for 6 weeks. These patients will be observed by research staff.
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
- •Emergency Department patients
- •Patients 18 years and older
- •Patients with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician will be observed.
- •Patients meeting these criteria who receive medications in the ED will be observed by research staff, evaluating efficacy and safety of the administered medication.
排除标准
- •There are no exclusion criteria per se as this is only observational research. The decision to administer the medication is at the discretion of the physician. Research protocols are only such that we are observing the efficacy and safety, which coincides the quality improvement purposes of this clinical protocol. Patients will be provided an Information Sheet and can opt to have their data removed.
- •Patients who are prisoners, children, will NOT have their data collected
研究组 & 干预措施
Olanzapine
Patients receiving 10 mg IM Olanzapine per the ED protocol
干预措施: Olanzapine (Drug)
Midazolam
Patients receiving 5 mg IM Midazolam per the ED protocol
干预措施: Midazolam (Drug)
结局指标
主要结局
Proportion of Patients Adequately Sedated at 15 minutes
时间窗: 15 minutes
Proportion of patients who achieve an AMSS score of \< 1 at 15 minutes
次要结局
- Proportion of Patients Adequately Sedated at 30 minutes(30 minutes)
- Proportion of Patients Adequately Sedated at 60 minutes(60 minutes)
- Proportion of Patients Adequately Sedated at 120 minutes(120 minutes)
- Safety Events(120 minutes)
研究者
Lauren Klein
Principal Investigator
Hennepin Healthcare Research Institute
