Uncomplicated Nausea and Vomiting in the Emergency Department

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778011
• Other study ID #: 0506018
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2008
• Last updated: June 27, 2012
• Start date: November 2005
• Est. completion date: December 2006

Study information

• Verified date: June 2012
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emergencies
• Nausea
• Vomiting

Intervention

Drug:
• Ondansetron
dosage
• Ondansetron
4 mg
• Metoclopramide
10 mg IV

Locations

Country	Name	City	State
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 minutes	No