NCT01406860终止不适用
Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.
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
- 19
- 试验地点
- 1
- 主要终点
- Pain Scale (Numerical Rating Scale for Pain)
研究概览
简要总结
The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old to 65 years old, diagnosis of primary headache
排除标准
- •Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected
- •ED Droperidol Protocol
- •Droperidol must NOT be used in patients with any of the following:
- •Known or suspected QT prolongation, including congenital long QT syndrome
- •Cardiac Disease [cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (< 50 bpm)]
- •History of the following:
- •Renal failure
- •Cerebrovascular disease
- •Diabetes or hypoglycemia
- •Alcoholism/alcohol abuse
- •Pituitary insufficiency
- •Hypothyroidism
- •Hypothermia
- •Advanced age (>65 yrs)
- •Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.
研究组 & 干预措施
Droperidol
Experimental
干预措施: Droperidol (Drug)
Metoclopramide + Diphenhydramine
Active Comparator
干预措施: Metoclopramide + diphenhydramine (Drug)
结局指标
主要结局
Pain Scale (Numerical Rating Scale for Pain)
时间窗: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)
Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain
次要结局
- Length of Stay(Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes))
- 24 Hour Pain Score(24 hours after discharge from ED)
- Adverse Effects(From the time when the treatment is initiated until the 24 hour follow-up phone survey)
研究者
Brett A Faine
Clinical Pharmacy Specialist
University of Iowa
研究点 (1)
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