Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00655642

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, metoclopramide, and promethazine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment
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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Metoclopramide hydrochloride Diphenhydramine citrate Ondansetron hydrochloride Ondansetron Diphenhydramine hydrochloride Metoclopramide

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

reduction in Visual Analog Scale (VAS) score for nausea [ Time Frame: 30 minute ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	March 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Patients will be randomized to intravenously receive ondansetron 4mg, metoclopramide 10 mg, promethazine 12.5 mg or a volume matched saline placebo. As an ED standard of care for vomiting, all patients will receive approximately 500 mL of normal saline hydration during the initial 30 minutes of the study. Nausea will be evaluated on a 100-mm visual analog scale (VAS) at time 0 and 30 minutes after treatment.

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

No publications provided

Responsible Party:	Vanderbilt University Medical Center ( Tyler W Barrett )
Study ID Numbers:	VUMC 0612369
Study First Received:	April 4, 2008
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00655642 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neurotransmitter Agents
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Antiemetics
Metoclopramide
Signs and Symptoms
Serotonin Antagonists
Promethazine
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Antipruritics

Nausea
Ondansetron
Dermatologic Agents
Tranquilizing Agents
Gastrointestinal Agents
Histamine Agents
Central Nervous System Depressants
Dopamine Antagonists
Anti-Allergic Agents
Antipsychotic Agents
Anesthetics, Local
Pharmacologic Actions
Serotonin Agents
Histamine Antagonists
Autonomic Agents

ClinicalTrials.gov processed this record on November 22, 2009