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

Nausea Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00655642
• Other study ID #: VUMC 0612369
• Status: Terminated
• Phase: N/A
• First received: April 4, 2008
• Last updated: September 30, 2013
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: September 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 171
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Nausea

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 30 minute assessments	No