A Phase 4 interventional study of Ondansetron and promethazine in Nausea and Vomiting, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-02-01.
Sponsored by University of New Mexico · Phase 4, Interventional, and Treatment
This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
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.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 120 is close to the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.
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University of New Mexico