Back to resultsUncomplicated Nausea and Vomiting in the Emergency Department
Primary Purpose
Nausea, Vomiting
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Ondansetron
Metoclopramide
Sponsored by
About this trial
This is an interventional treatment trial for Nausea focused on measuring Nausea, Vomiting, Ondansetron, Metoclopramide, Randomized, Double-Blind, nausea and vomiting in the emergency department
Eligibility 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
Sites / Locations
- York Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00778011
Brief Title
Uncomplicated Nausea and Vomiting in the Emergency Department
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
WellSpan Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Nausea, Vomiting, Ondansetron, Metoclopramide, Randomized, Double-Blind, nausea and vomiting in the emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Ondansetron 2 mg IV
Intervention Description
dosage
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Ondansetron 4 mg IV
Intervention Description
4 mg
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
Metoclopramide 10 mg IV
Intervention Description
10 mg IV
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Pollack, MD, PhD
Organizational Affiliation
York Hospital Emergency Department Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Uncomplicated Nausea and Vomiting in the Emergency Department
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