A Randomized, Double Blind, and Placebo-Controlled Trial Comparing Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult Emergency Department.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.
研究概览
简要总结
The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.
We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age 18 or older who present to the ED with a complaint requiring antiemetic treatment who do not meet the exclusion criteria.
排除标准
- •Patients less than 18 years of age
- •Unstable patients with SBP < 90
- •Patients with a stated or documented allergy to any of the study medications
- •Patients whose nausea rating if < 40 on the pretreatment VAS scale
- •Patients who have received a commonly accepted antiemetic within the previous 24 hours
- •Patients unwilling or unable to complete the assessment tool before and 30 minutes after study drug dosing
研究组 & 干预措施
Ondansetron
Ondansetron 4 mg intravenous administration
干预措施: Ondansetron (Drug)
Metoclopramide
Metoclopramide 10 mg intravenous administration
干预措施: Metoclopramide (Drug)
Promethazine
Promethazine 10 mg intravenous administration
干预措施: Promethazine (Drug)
Saline Placebo
Volume-matched saline placebo
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.
时间窗: Baseline and 30 minute assessments
Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words "Least Severe" on the left and "Most Severe" on the right. The possible values range from 0 to 100mm with 0 at the "Least Severe" extreme and 100 at the "Most Severe" extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes).
次要结局
未报告次要终点
研究者
Tyler Barrett
Assistant Professor of Emergency Medicine
Vanderbilt University