A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
Information source: University of New Mexico
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Vomiting
Intervention: Ondansetron (Drug); promethazine (Drug)
Phase: Phase 4
Sponsored by: University of New Mexico
Official(s) and/or principal investigator(s):
Darren A Braude, MD, MPH, Principal Investigator, Affiliation: University of New Mexico
This was a trial comparing two commonly used medications for nausea and vomiting,
ondansetron and promethazine, 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Reduction in nausea on a VAS.
Change in sedation on a VAS
Change in anxiety on a VAS
Need for rescue medication at 30 minutes
Patient satisfaction at follow-up
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
Minimum age: 18 Years.
Maximum age: N/A.
- Age 18 or older
- Chief complaint of nausea or vomiting
- 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
Locations and Contacts
University of New Mexico Hospital Emergency Department, Albuquerque, New Mexico 87131, United States
Starting date: October 2003
Last updated: January 31, 2007