Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

April 23, 2014 updated by: Daniel Wu, MD, Emory University
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date.

Inclusion Criteria:

Patients presenting to the ED with at least one of the following

  • nausea
  • vomiting documented in the ED

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Hospital
      • Atlanta, Georgia, United States
        • Grady Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting to the ED with at least one of the following
  • Nausea
  • Vomiting documented in the ED

Exclusion Criteria:

  • Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide
  • Patients with missed last menstrual period
  • Pregnancy
  • Age < 18 years old
  • Treatment with antineoplastic agents within 7 days prior to randomization
  • Irritable bowel syndrome
  • Gastroparesis
  • Suspected gastrointestinal bleed
  • Suspected intestinal obstruction
  • Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)
  • Traumatic brain injury upon admission to ED
  • Intracranial hemorrhage upon admission to ED
  • Patients unable to read, write or communicate in the English language
  • Patients leaving the ED against medical advice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prochlorperazine
Patients receiving Prochlorperazine 10mg IV
Drug: Prochlorperazine
Patients receiving Prochlorperazine
Active Comparator: Ondansetron
Patient receiving Ondansetron 4mg IV
Drug: Ondansetron
Patients receiving Ondansetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vomiting at 0 to 120 Min.
Time Frame: 0 to 120 minutes after receiving medication
0 to 120 minutes after receiving medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea at 0 to 120 Min
Time Frame: 0 to 120 minutes after receiving medication
100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea
0 to 120 minutes after receiving medication
Akithisia at 0 to 120 Min
Time Frame: 0 to 120 min after receiving medication
0 to 120 min after receiving medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: John Patka, PharmD, Grady Memorial Hospital
  • Principal Investigator: Daniel T Wu, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0998-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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