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.”

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.

Study Type: Interventional

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

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: ondansetron, metoclopramide, and promethazine
  • 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.

Primary Measures

• reduction in Visual Analog Scale (VAS) score for nausea
  • Time Frame: 30 minute
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

Tyler W Barrett, MD Principal Investigator Vanderbilt University  

Overall Contact: Fiona E. Remple 615-936-8379 fiona.remple@vanderbilt.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00655642

Study ID Number: VUMC 0612369

ClinicalTrials.gov Identifier: NCT00655642

Health Authority: United States: Institutional Review Board