Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(Conditional analysis showed observed differences were significantly less than power calculations)
Information provided by (Responsible Party):
Tyler Barrett, Vanderbilt University Identifier:
First received: April 4, 2008
Last updated: September 30, 2013
Last verified: September 2013

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.

Condition Intervention
Drug: Ondansetron
Drug: Metoclopramide
Drug: Promethazine
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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. [ Time Frame: 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).

Enrollment: 171
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ondansetron
Ondansetron 4 mg intravenous administration
Drug: Ondansetron
4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
Active Comparator: Metoclopramide
Metoclopramide 10 mg intravenous administration
Drug: Metoclopramide
10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
Active Comparator: Promethazine
Promethazine 10 mg intravenous administration
Drug: Promethazine
12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
Placebo Comparator: Saline Placebo
Volume-matched saline placebo
Drug: Normal Saline
Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00655642

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37240
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Tyler W Barrett, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Tyler Barrett, Assistant Professor of Emergency Medicine, Vanderbilt University Identifier: NCT00655642     History of Changes
Other Study ID Numbers: VUMC 0612369
Study First Received: April 4, 2008
Results First Received: March 21, 2011
Last Updated: September 30, 2013

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents
Anesthetics, Local
Anesthetics processed this record on April 25, 2017