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

Primary Purpose

Nausea

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Metoclopramide
Promethazine
Normal Saline
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ondansetron

Metoclopramide

Promethazine

Saline Placebo

Arm Description

Ondansetron 4 mg intravenous administration

Metoclopramide 10 mg intravenous administration

Promethazine 10 mg intravenous administration

Volume-matched saline placebo

Outcomes

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.
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).

Secondary Outcome Measures

Full Information

First Posted
April 4, 2008
Last Updated
September 30, 2013
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00655642
Brief Title
Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Conditional analysis showed observed differences were significantly less than power calculations
Study Start Date
March 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Description
Ondansetron 4 mg intravenous administration
Arm Title
Metoclopramide
Arm Type
Active Comparator
Arm Description
Metoclopramide 10 mg intravenous administration
Arm Title
Promethazine
Arm Type
Active Comparator
Arm Description
Promethazine 10 mg intravenous administration
Arm Title
Saline Placebo
Arm Type
Placebo Comparator
Arm Description
Volume-matched saline placebo
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Intervention Description
10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
Intervention Type
Drug
Intervention Name(s)
Promethazine
Intervention Description
12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Baseline and 30 minute assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler W Barrett, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20825792
Citation
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.
Results Reference
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Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

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