Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Vomiting at 0 to 120 Min.
研究概览
简要总结
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.
详细描述
Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date.
Inclusion Criteria:
Patients presenting to the ED with at least one of the following
- nausea
- vomiting documented in the ED
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients presenting to the ED with at least one of the following
- •Vomiting documented in the ED
排除标准
- •Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide
- •Patients with missed last menstrual period
- •Pregnancy
- •Age < 18 years old
- •Treatment with antineoplastic agents within 7 days prior to randomization
- •Irritable bowel syndrome
- •Gastroparesis
- •Suspected gastrointestinal bleed
- •Suspected intestinal obstruction
- •Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)
- •Traumatic brain injury upon admission to ED
- •Intracranial hemorrhage upon admission to ED
- •Patients unable to read, write or communicate in the English language
- •Patients leaving the ED against medical advice
研究组 & 干预措施
Prochlorperazine
Patients receiving Prochlorperazine 10mg IV
干预措施: Prochlorperazine (Drug)
Ondansetron
Patient receiving Ondansetron 4mg IV
干预措施: Ondansetron (Drug)
结局指标
主要结局
Vomiting at 0 to 120 Min.
时间窗: 0 to 120 minutes after receiving medication
次要结局
- Nausea at 0 to 120 Min(0 to 120 minutes after receiving medication)
- Akithisia at 0 to 120 Min(0 to 120 min after receiving medication)
研究者
Daniel Wu, MD
Associate Professor
Emory University