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临床试验/NCT00429832
NCT00429832已完成4 期

A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

University of New Mexico2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2003年10月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
120
试验地点
2
主要终点
Reduction in nausea on a VAS.

研究概览

简要总结

This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.

详细描述

Nausea and vomiting are common complaints in the emergency department (ED). There are many pharmacologic agents used for the treatment of these complaints. None are new nor experimental. Very little research has been done in the ED setting to determine which of these agents is most effective with the least adverse effects. Our own previous research found that droperidol but not prochlorperazine and metoclopramide is more effective than placebo. Because of the recent FDA black box warning added to droperidol, the use of this agent has suddenly ceased in many EDs. Promethazine remains a very commonly used antiemetic in many EDs but one recent study found it less effective than prochlorperazine which was in turn found no more effective than placebo in our own study. As a result many physicians have turned to ondansetron, a newer and more expensive agent. Experience among anesthesiologists and oncologists has shown ondansetron to be highly effective with a minimum of adverse effects. These patient populations, however, are very different from those found in the ED. It is our hypothesis that promethazine and ondansetron are equally effective for the ED treatment of unselected patients with nausea and vomiting with similar rates of adverse effects.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • Chief complaint of nausea or vomiting

排除标准

  • Age less than 18
  • unable to provide informed consent
  • rate nausea at < 40 mm on 100 mm VAS
  • received antiemetic within 24 hours
  • pregnant or possibly pregnant
  • reported allergy to either study medication
  • received more than 1 liter of intravenous fluids
  • their primary ED physician declined to have patient participate

结局指标

主要结局

Reduction in nausea on a VAS.

次要结局

  • Change in sedation on a VAS
  • Change in anxiety on a VAS
  • Need for rescue medication at 30 minutes
  • Patient satisfaction at follow-up

研究者

申办方类型
Other

研究点 (2)

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