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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)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00655642
First received: April 4, 2008
Last updated: May 9, 2011
Last verified: May 2011
History of Changes
  Purpose

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
Nausea
 Drug: Ondansetron
Drug: Metoclopramide
Drug: Promethazine
Drug: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655642

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

Publications:

Responsible Party: Tyler W Barrett, Vanderbilt University Medical Center
ClinicalTrials.gov 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: May 9, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Promethazine
Ondansetron
Diphenhydramine
Metoclopramide
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013