Droperidol on Prevention of Emesis From Cannabinoid Hyperemesis Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change from baseline in symptoms after treatment with droperidol and diphenhydramine
研究概览
简要总结
The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.
详细描述
Patients presenting to the Emergency Department with nausea, vomiting and/or abdominal pain with a significant history of cannabis use and symptoms in a cyclic pattern will be assessed for study inclusion. After given written informed consent, patients will be treated with droperidol and diphenhydramine and symptoms will be assessed using a visual analog scale at time intervals up to 120 minutes. Patient will then be contacted at 24 and 48 hour intervals to assess symptoms on the same scale. This is a multicenter, prospective interventional study with results compared to a historical cohort using haloperidol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18 years of age or older and presenting with cannabis hyperemesis syndrome requiring intravenous medication.
排除标准
- •any patient with a contraindication to the use of droperidol
- •Corrected QT interval on ECG greater than 440 milliseconds for males and greater than 450 milliseconds for females
- •any prisoners
- •pregnant females.
研究组 & 干预措施
Intervention
Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once
干预措施: Droperidol Injectable Product (Drug)
Intervention
Patients who receive droperidol 2.5mg intravenous once and diphenhydramine 25mg intravenous once
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Change from baseline in symptoms after treatment with droperidol and diphenhydramine
时间窗: Baseline, 30 minutes, 60 minutes and 120 minutes. Then at 24 hours and 48 hours.
The Visual Analog Scale is a 100-mm patient-reported score measurement used to assess nausea and/or vomiting and/or abdominal pain. Possible scores range from 0 (symptom-free) to 10 (worst possible symptom)
次要结局
未报告次要终点