Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea
Intervention: Ondansetron (Drug); Metoclopramide (Drug); Promethazine (Drug); Normal Saline (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Tyler W Barrett, MD, Principal Investigator, Affiliation: Vanderbilt University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Vanderbilt University Medical Center, Nashville, Tennessee 37240, United States
Additional Information
Starting date: March 2007
Last updated: September 30, 2013
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