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

NCT ID: NCT00655642

Last Updated: 2013-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-10-31

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.

Detailed Description

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Conditions

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Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ondansetron

Ondansetron 4 mg intravenous administration

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Metoclopramide

Metoclopramide 10 mg intravenous administration

Group Type ACTIVE_COMPARATOR

Metoclopramide

Intervention Type DRUG

10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Promethazine

Promethazine 10 mg intravenous administration

Group Type ACTIVE_COMPARATOR

Promethazine

Intervention Type DRUG

12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Saline Placebo

Volume-matched saline placebo

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter

Interventions

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Ondansetron

4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Intervention Type DRUG

Metoclopramide

10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Intervention Type DRUG

Promethazine

12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Intervention Type DRUG

Normal Saline

Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Tyler Barrett

Assistant Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tyler W Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Barrett TW, DiPersio DM, Jenkins CA, Jack M, McCoin NS, Storrow AB, Singleton LM, Lee P, Zhou C, Slovis CM. A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. Am J Emerg Med. 2011 Mar;29(3):247-55. doi: 10.1016/j.ajem.2009.09.028. Epub 2010 Mar 26.

Reference Type RESULT
PMID: 20825792 (View on PubMed)

Other Identifiers

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VUMC 0612369

Identifier Type: -

Identifier Source: org_study_id