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

Not Applicable

Terminated

• Conditions: Nausea
• Interventions: Drug: Ondansetron; Drug: Metoclopramide; Drug: Promethazine; Drug: Normal Saline

• Registration Number: NCT00655642
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2011-03-21
• Results First Submitted QC: 2011-04-12
• Results First Posted: 2011-05-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 171

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron	Ondansetron 4 mg intravenous administration
Metoclopramide	Metoclopramide	Metoclopramide 10 mg intravenous administration
Promethazine	Promethazine	Promethazine 10 mg intravenous administration
Saline Placebo	Normal Saline	Volume-matched saline placebo

Primary Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States