Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Nausea

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Metoclopramide
* Drug: Promethazine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients age 18 or older who present to the ED with a complaint requiring antiemetic treatment who do not meet the exclusion criteria. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ondansetron<br>Ondansetron 4 mg intravenous administration | Drug: Ondansetron<br>* 4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter<br>|
| Active Comparator: Metoclopramide<br>Metoclopramide 10 mg intravenous administration | Drug: Metoclopramide<br>* 10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter<br>|
| Active Comparator: Promethazine<br>Promethazine 10 mg intravenous administration | Drug: Promethazine<br>* 12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter<br>|
| Placebo Comparator: Saline Placebo<br>Volume-matched saline placebo | Drug: Normal Saline<br>* Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | Baseline and 30 minute assessments |