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A RCT of Ondansetron and Promethazine in the Treatment of 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. Identifier: NCT00429832
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : February 1, 2007
Information provided by:
University of New Mexico

Brief Summary:
This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Ondansetron Drug: promethazine Phase 4

Detailed Description:
Nausea and vomiting are common complaints in the emergency department (ED). There are many pharmacologic agents used for the treatment of these complaints. None are new nor experimental. Very little research has been done in the ED setting to determine which of these agents is most effective with the least adverse effects. Our own previous research found that droperidol but not prochlorperazine and metoclopramide is more effective than placebo. Because of the recent FDA black box warning added to droperidol, the use of this agent has suddenly ceased in many EDs. Promethazine remains a very commonly used antiemetic in many EDs but one recent study found it less effective than prochlorperazine which was in turn found no more effective than placebo in our own study. As a result many physicians have turned to ondansetron, a newer and more expensive agent. Experience among anesthesiologists and oncologists has shown ondansetron to be highly effective with a minimum of adverse effects. These patient populations, however, are very different from those found in the ED. It is our hypothesis that promethazine and ondansetron are equally effective for the ED treatment of unselected patients with nausea and vomiting with similar rates of adverse effects.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
Study Start Date : October 2003
Study Completion Date : November 2005

Primary Outcome Measures :
  1. Reduction in nausea on a VAS.

Secondary Outcome Measures :
  1. Change in sedation on a VAS
  2. Change in anxiety on a VAS
  3. Need for rescue medication at 30 minutes
  4. Patient satisfaction at follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 or older
  • Chief complaint of nausea or vomiting

Exclusion Criteria:

  • Age less than 18
  • unable to provide informed consent
  • rate nausea at < 40 mm on 100 mm VAS
  • received antiemetic within 24 hours
  • pregnant or possibly pregnant
  • reported allergy to either study medication
  • received more than 1 liter of intravenous fluids
  • their primary ED physician declined to have patient participate

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 identifier (NCT number): NCT00429832

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United States, New Mexico
University of New Mexico Hospital Emergency Department
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
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Principal Investigator: Darren A Braude, MD, MPH University of New Mexico
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00429832    
Other Study ID Numbers: 03-006
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: February 1, 2007
Last Verified: January 2007
Keywords provided by University of New Mexico:
Nausea, vomiting, antiemetic
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents