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Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00590317
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
Sponsor:
Information provided by (Responsible Party):
Daniel Wu, MD, Emory University

Study Description
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Brief Summary:
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Condition or disease Intervention/treatment Phase
Nausea and Vomiting Drug: Prochlorperazine Drug: Ondansetron Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
Study Start Date : March 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Vomiting at 0 to 120 Min. [ Time Frame: 0 to 120 minutes after receiving medication ]

Secondary Outcome Measures :
  1. 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

  2. Akithisia at 0 to 120 Min [ Time Frame: 0 to 120 min after receiving medication ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590317


Locations
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United States, Georgia
Grady Hospital
Atlanta, Georgia, United States, 30303
Grady Memorial Hospital
Atlanta, Georgia, United States
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: John Patka, PharmD Grady Memorial Hospital
Principal Investigator: Daniel T Wu, MD Emory University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Daniel Wu, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00590317    
Other Study ID Numbers: 0998-2005
First Posted: January 10, 2008    Key Record Dates
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Emergencies
Nausea
Vomiting
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Ondansetron
Prochlorperazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Dopamine Antagonists
Dopamine Agents