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

October 22, 2008
June 27, 2012
November 2005
December 2006   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00778011 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Uncomplicated Nausea and Vomiting in the Emergency Department
Ondansetron 4 mg vs. 2 mg vs. Metoclopramide 10 mg for Nausea and Vomiting in the Emergency Department: A Randomized, Double-Blind Clinical Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Nausea
  • Vomiting
  • Drug: Ondansetron
    dosage
    Other Name: Ondansetron 2 mg IV
  • Drug: Ondansetron
    4 mg
    Other Name: Ondansetron 4 mg IV
  • Drug: Metoclopramide
    10 mg IV
    Other Name: Metoclopramide 10 mg IV
  • Active Comparator: 1
    Intervention: Drug: Ondansetron
  • Active Comparator: 2
    Intervention: Drug: Ondansetron
  • Active Comparator: 3
    Intervention: Drug: Metoclopramide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
137
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00778011
0506018
No
Marc Pollack, MD, PhD, York Hospital Emergency Medicine Physician
WellSpan Health
Not Provided
Principal Investigator: Marc Pollack, MD, PhD York Hospital Emergency Department Physician
WellSpan Health
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP