A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department|
- 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
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||November 2005|
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.
|United States, New Mexico|
|University of New Mexico Hospital Emergency Department|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Darren A Braude, MD, MPH||University of New Mexico|