Ondansetron 4 mg vs. 2 mg vs. Metoclopramide 10 mg for Nausea and Vomiting in the Emergency Department: A Randomized, Double-Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- To delineate whether a high vs low dose of Ondansetron in better as opposed to an alternate medication -- Metoclopramide in the ED setting for uncomplicated nausea and vomiting.
研究概览
简要总结
Nausea and vomiting is a common complaint in the emergency department. Treatment is important for many reasons. In addition to patient comfort, there are adverse effects secondary to vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Two mediations common used for nausea in ED patients include Ondanesetron and Metoclopramide.
详细描述
This study will compare Ondansetron 4 mg vs 2 mg vs Metoclopramide 10 mg to look for efficacy in nausea and vomiting treatment for patients in the ED with many different causes. We will also look for cost effectiveness as well, since Metoclopramide is much less expensive than Ondansetron, which is less expensive at lower doses. There is little research about nausea medication in the ED literature even though these medications are used frequently in the ED for many causes of nausea.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older with nausea and at least 1 episode vomiting in the last 12 hours presenting to the York Hospital Emergency Department
排除标准
- •Patients known to have hypersensitivity to the drugs ondansetron or metoclopramide
- •gastrointestinal hemorrhage, mechanical obstruction or perforation
- •patients with pheochromocytoma
- •seizure disorder
- •patients receiving other drugs which are likely to cause extrapyramidal reactions such as butapherones and phenothiazines
- •patients experiencing hyperemesis gravidum
- •patients unable to understand the informed consent (intoxicated, Spanish speaking)
- •prior antiemetics within 12 hours
- •inability to perform visual analog scale
- •renal dialysis
研究组 & 干预措施
1
干预措施: Ondansetron (Drug)
2
干预措施: Ondansetron (Drug)
3
干预措施: Metoclopramide (Drug)
结局指标
主要结局
To delineate whether a high vs low dose of Ondansetron in better as opposed to an alternate medication -- Metoclopramide in the ED setting for uncomplicated nausea and vomiting.
时间窗: 30 minutes
次要结局
未报告次要终点