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.”

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.

Intervention(s) in this Clinical Trial

• Drug: Ondansetron
  • 4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
• Drug: Metoclopramide
  • 10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
• Drug: Promethazine
  • 12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
• Drug: Normal Saline
  • Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Ondansetron
  • Ondansetron 4 mg intravenous administration
• Active Comparator: Metoclopramide
  • Metoclopramide 10 mg intravenous administration
• Active Comparator: Promethazine
  • Promethazine 10 mg intravenous administration
• Placebo Comparator: Saline Placebo
  • Volume-matched saline placebo

Primary 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.
  • Time Frame: Baseline and 30 minute assessments
    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 Investigator: Vanderbilt University Other

Overall Clinical Trial Officials and Contacts

Tyler W Barrett, MD Principal Investigator Vanderbilt University  

Information obtained from ClinicalTrials.gov on February 09, 2012

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