跳至主要内容
临床试验/NCT03899506
NCT03899506终止不适用

Prospective Observational Investigation of Olanzapine Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department

Hennepin Healthcare Research Institute1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2018年6月18日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren Klein

Principal Investigator

Hennepin Healthcare Research Institute

研究点 (1)

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