Uncomplicated Nausea and Vomiting in the Emergency Department

This study has been completed.
Sponsor:
Information provided by:
WellSpan Health
ClinicalTrials.gov Identifier:
NCT00778011
First received: October 22, 2008
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

Nausea and vomiting is a common complaint in the emergency department. Treatment is important for many reasons. In addition to patient comfort, there are adverse effects secondary to vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Two mediations common used for nausea in ED patients include Ondanesetron and Metoclopramide.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Ondansetron 4 mg vs. 2 mg vs. Metoclopramide 10 mg for Nausea and Vomiting in the Emergency Department: A Randomized, Double-Blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by WellSpan Health:

Primary Outcome Measures:
  • To delineate whether a high vs low dose of Ondansetron in better as opposed to an alternate medication -- Metoclopramide in the ED setting for uncomplicated nausea and vomiting. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: November 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Ondansetron
dosage
Other Name: Ondansetron 2 mg IV
Active Comparator: 2 Drug: Ondansetron
4 mg
Other Name: Ondansetron 4 mg IV
Active Comparator: 3 Drug: Metoclopramide
10 mg IV
Other Name: Metoclopramide 10 mg IV

Detailed Description:

This study will compare Ondansetron 4 mg vs 2 mg vs Metoclopramide 10 mg to look for efficacy in nausea and vomiting treatment for patients in the ED with many different causes. We will also look for cost effectiveness as well, since Metoclopramide is much less expensive than Ondansetron, which is less expensive at lower doses. There is little research about nausea medication in the ED literature even though these medications are used frequently in the ED for many causes of nausea.

  Eligibility

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

Inclusion Criteria:

  • 18 years or older with nausea and at least 1 episode vomiting in the last 12 hours presenting to the York Hospital Emergency Department

Exclusion Criteria:

  • Patients known to have hypersensitivity to the drugs ondansetron or metoclopramide
  • gastrointestinal hemorrhage, mechanical obstruction or perforation
  • patients with pheochromocytoma
  • seizure disorder
  • patients receiving other drugs which are likely to cause extrapyramidal reactions such as butapherones and phenothiazines
  • patients experiencing hyperemesis gravidum
  • patients unable to understand the informed consent (intoxicated, Spanish speaking)
  • prior antiemetics within 12 hours
  • inability to perform visual analog scale
  • renal dialysis
  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: NCT00778011

Locations
United States, Pennsylvania
York Hospital
York, Pennsylvania, United States, 17405
Sponsors and Collaborators
WellSpan Health
Investigators
Principal Investigator: Marc Pollack, MD, PhD York Hospital Emergency Department Physician
  More Information

No publications provided

Responsible Party: Marc Pollack, MD, PhD, York Hospital Emergency Medicine Physician
ClinicalTrials.gov Identifier: NCT00778011     History of Changes
Other Study ID Numbers: 0506018
Study First Received: October 22, 2008
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by WellSpan Health:
Nausea
Vomiting
Ondansetron
Metoclopramide
Randomized
Double-Blind
nausea and vomiting in the emergency department

Additional relevant MeSH terms:
Emergencies
Nausea
Vomiting
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on September 22, 2014