NCT01892995Unknown不适用
Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Beck Scale for Suicidal Ideation
研究概览
简要总结
This study will enroll patients presenting to the emergency department with acute suicidal ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial measurements will be made in the ED and at follow-up intervals.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation.
排除标准
- •-Poor vital sign stability hypoxia: O2 < 95%, hypotension: SBP< 90 hypertension: SBP>180 Heart rate: < 50 or >120 Respiratory Rate: <10 or >30
- •Altered mental status or intoxication
- •Patient is unwilling to participate or provide informed consent
- •Any allergy to ketamine or diphenhydramine
- •Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis
- •Pregnancy or breast feeding
- •Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
- •Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
- •Presence of intracranial mass or vascular lesion.
- •Presence of a history of psychosis or hallucinations (as assessed by electronic chart review)
- •Weight greater than 115 kg or less than 45kg
- •History of increased intracranial pressure/hypertensive hydrocephalus
- •Non-English speaking patients
- •Patient is acutely psychotic
- •Provider feels that patient currently or likely will require chemical and/or physical restraints
- •History of prolonged QT-interval
研究组 & 干预措施
Ketamine
Experimental
active arm
干预措施: Ketamine (Drug)
Diphenhydramine
Sham Comparator
sham arm
干预措施: Ketamine (Drug)
Saline
Placebo Comparator
placebo
干预措施: Ketamine (Drug)
结局指标
主要结局
Change in Beck Scale for Suicidal Ideation
时间窗: 2 hours
次要结局
未报告次要终点
研究者
Steven Schauer
CPT
Brooke Army Medical Center
研究点 (1)
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