Uncomplicated Nausea and Vomiting in the Emergency Department

NCT00778011 | Completed Phase 4

• 1 other identifier: 0506018
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nausea; Vomiting

Keywords

Nausea; Vomiting; Ondansetron; Metoclopramide; Randomized; Double-Blind; nausea and vomiting in the emergency department

Outcome Measures

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.

  30 minutes

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: Ondansetron

2

ACTIVE COMPARATOR

Drug: Ondansetron

3

ACTIVE COMPARATOR

Drug: Metoclopramide

Interventions

Ondansetron DRUG

dosage

Also known as: Ondansetron 2 mg IV

1

Metoclopramide DRUG

10 mg IV

Also known as: Metoclopramide 10 mg IV

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

York Hospital

York, Pennsylvania, 17405, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ondansetron; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Marc Pollack, MD, PhD

  York Hospital Emergency Department Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: November 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

US (1)