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

NCT00655642 | Terminated Results

• 1 other identifier: VUMC 0612369
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Ondansetron

ACTIVE COMPARATOR

Ondansetron 4 mg intravenous administration

Drug: Ondansetron

Metoclopramide

ACTIVE COMPARATOR

Metoclopramide 10 mg intravenous administration

Drug: Metoclopramide

Promethazine

ACTIVE COMPARATOR

Promethazine 10 mg intravenous administration

Drug: Promethazine

Saline Placebo

PLACEBO COMPARATOR

Volume-matched saline placebo

Drug: Normal Saline

Interventions

Ondansetron DRUG

4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Ondansetron

Metoclopramide DRUG

10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Metoclopramide

Promethazine DRUG

12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter

Promethazine

Normal Saline DRUG

Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter

Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37240, United States

Location

Related 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: 10.1016/j.ajem.2009.09.028. Epub 2010 Mar 26.

  PMID: 20825792 RESULT

MeSH Terms

Conditions

Nausea

Interventions

Ondansetron; Metoclopramide; Promethazine; Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Propylamines; Amines; Phenothiazines; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Early termination resulted in failure to meet our predetermined sample size.

Results Point of Contact

• Title: Dr. Tyler Barrett
• Organization: Vanderbilt University

tyler.barrett@vanderbilt.edu

6159360253

Study Officials

• Tyler W Barrett, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: March 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 30, 2013
• Results First Posted: May 9, 2011

Record last verified: 2013-09

Locations

US (1)