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OpenTrials
Completed

NCT Number: NCT00778011

Uncomplicated Nausea and Vomiting in the Emergency Department

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.

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Key information

Conditions

Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

York Hospital

York, Pennsylvania, 17405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

dosage

Other names: Ondansetron 2 mg IV

Metoclopramide

Drug

10 mg IV

Other names: Metoclopramide 10 mg IV

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

WellSpan Health

Other

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 23, 2008
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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