An Observational Study of Anti-Psychotic Medication for the Treatment of Agitation in the Emergency Department
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction of Agitation as Measured by the PANSS-CC
研究概览
简要总结
There is limited information on the best psychoactive medication to treat agitated patients in the emergency department. The intent of this study is to fill in knowledge gaps in the current practice of treating psychiatric patients in the acute care setting. The purpose of this study is to determine the best treatment for agitated psychiatric patients in the emergency department.
详细描述
Patients with psychiatric complaints frequently present for evaluation and treatment in emergency departments across the country. In particular, agitation in the emergency department can have life-threatening consequences for both patients and staff, and so patients are frequently given medications to reduce their level of agitation and permit medical examination.
Primary and secondary objectives:
The primary objective of this study is to compare the efficacy and effectiveness of inhaled loxapine (Adasuve) vs. traditional emergency department treatment with intramuscular haloperidol with and without lorazepam in patients who present to the emergency department in an acutely agitated state. The Positive and Negative Syndrome Scale (PANSS-EC), Agitation and Calmness Evaluation Scale (ACES) will be used as measurements of agitation and Barnes akathisia scale will be used as measurements of side effects.
There are five secondary objectives: (1) To assess the level of agitation of psychiatric patients presenting to the emergency department using the PANSS-EC, ACES and Barnes scale; (2) To determine the effect of the level of agitation related to medication treatment and physical restraint using the PANSS-EC; (3) To determine the complication rate of the various medications administered with and without physical restraint; (4) To compare the effectiveness of various pharmacologic agents used in the emergency department for agitation using the delta of agitation over time (5) To determine the effect of the treatment choice on emergency department throughout time using emergency department (ED) throughput time.
Hypothesis:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients at least 18 years of age and less than 65 years of age
- •Patients must be emergency department patients during time of study
- •All patients will be evaluated by the emergency physician to provide medical clearance- patients must be considered by the emergency physicians to be clinically agitated and to be clinically appropriate candidates for treatment with a medication
- •Each patient, or a surrogate, must understand the nature of the study and must sign an informed consent document
- •English speaking patients
排除标准
- •Female patients who are either pregnant or breast-feeding
- •Medically unstable patients
- •Patients who have delirium or dementia
- •Prisoners
- •Patients <18 or >65 years old
- •Non-English speaking patients
- •Contraindications for use for people with asthma, COPD, and other acute respiratory conditions
结局指标
主要结局
Reduction of Agitation as Measured by the PANSS-CC
时间窗: Three Hours
Patients will receive either an inhaled loxapine or the traditional treatment of haloperidol and will be observed over a three hour period to compare effectiveness of treatment.
次要结局
未报告次要终点
研究者
Leslie Zun, MD
Chairman of Emergency Department
Mt Sinai Hospital, Chicago