Trial | NCT00778011  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    137
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.
Study Started
Nov 30
2005
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Jun 28
2012
Estimate

Drug Ondansetron

dosage

  • Other names: Ondansetron 2 mg IV

Drug Ondansetron

4 mg

  • Other names: Ondansetron 4 mg IV

Drug Metoclopramide

10 mg IV

  • Other names: Metoclopramide 10 mg IV

1 Active Comparator

2 Active Comparator

3 Active Comparator

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
No Results Posted