Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00429832
First received: January 31, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Nausea
Vomiting
Drug: Ondansetron
Drug: promethazine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

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

Secondary Outcome Measures:
  • Change in sedation on a VAS
  • Change in anxiety on a VAS
  • Need for rescue medication at 30 minutes
  • Patient satisfaction at follow-up

Estimated Enrollment: 120
Study Start Date: October 2003
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429832

Locations
United States, New Mexico
University of New Mexico Hospital Emergency Department
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
GlaxoSmithKline
Investigators
Principal Investigator: Darren A Braude, MD, MPH University of New Mexico
  More Information

No publications provided by University of New Mexico

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00429832     History of Changes
Other Study ID Numbers: 03-006
Study First Received: January 31, 2007
Last Updated: January 31, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Nausea, vomiting, antiemetic

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
Diphenhydramine
Ondansetron
Promethazine
Anesthetics
Anesthetics, Local
Anti-Allergic Agents
Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on November 27, 2014