A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
Primary Purpose
Nausea, Vomiting
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
promethazine
Sponsored by
About this trial
This is an interventional treatment trial for Nausea focused on measuring Nausea, vomiting, antiemetic
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Chief complaint of nausea or vomiting
Exclusion Criteria:
- Age less than 18
- unable to provide informed consent
- rate nausea at < 40 mm on 100 mm VAS
- received antiemetic within 24 hours
- pregnant or possibly pregnant
- reported allergy to either study medication
- received more than 1 liter of intravenous fluids
- their primary ED physician declined to have patient participate
Sites / Locations
- University of New Mexico Hospital Emergency Department
Outcomes
Primary Outcome Measures
Reduction in nausea on a VAS.
Secondary Outcome Measures
Change in sedation on a VAS
Change in anxiety on a VAS
Need for rescue medication at 30 minutes
Patient satisfaction at follow-up
Full Information
NCT ID
NCT00429832
First Posted
January 31, 2007
Last Updated
January 31, 2007
Sponsor
University of New Mexico
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00429832
Brief Title
A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
Official Title
A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of New Mexico
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
Detailed Description
Nausea and vomiting are common complaints in the emergency department (ED). There are many pharmacologic agents used for the treatment of these complaints. None are new nor experimental. Very little research has been done in the ED setting to determine which of these agents is most effective with the least adverse effects. Our own previous research found that droperidol but not prochlorperazine and metoclopramide is more effective than placebo. Because of the recent FDA black box warning added to droperidol, the use of this agent has suddenly ceased in many EDs. Promethazine remains a very commonly used antiemetic in many EDs but one recent study found it less effective than prochlorperazine which was in turn found no more effective than placebo in our own study. As a result many physicians have turned to ondansetron, a newer and more expensive agent. Experience among anesthesiologists and oncologists has shown ondansetron to be highly effective with a minimum of adverse effects. These patient populations, however, are very different from those found in the ED. It is our hypothesis that promethazine and ondansetron are equally effective for the ED treatment of unselected patients with nausea and vomiting with similar rates of adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Nausea, vomiting, antiemetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Type
Drug
Intervention Name(s)
promethazine
Primary Outcome Measure Information:
Title
Reduction in nausea on a VAS.
Secondary Outcome Measure Information:
Title
Change in sedation on a VAS
Title
Change in anxiety on a VAS
Title
Need for rescue medication at 30 minutes
Title
Patient satisfaction at follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Chief complaint of nausea or vomiting
Exclusion Criteria:
Age less than 18
unable to provide informed consent
rate nausea at < 40 mm on 100 mm VAS
received antiemetic within 24 hours
pregnant or possibly pregnant
reported allergy to either study medication
received more than 1 liter of intravenous fluids
their primary ED physician declined to have patient participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren A Braude, MD, MPH
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Hospital Emergency Department
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18304050
Citation
Braude D, Crandall C. Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial. Acad Emerg Med. 2008 Mar;15(3):209-15. doi: 10.1111/j.1553-2712.2008.00060.x.
Results Reference
derived
Learn more about this trial
A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
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