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| Sponsor: | University of New Mexico |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT00429832 |
Purpose
This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea Vomiting |
Drug: Ondansetron Drug: promethazine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department |
| Estimated Enrollment: | 120 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | 03-006 |
| Study First Received: | January 31, 2007 |
| Last Updated: | January 31, 2007 |
| ClinicalTrials.gov Identifier: | NCT00429832 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Nausea, vomiting, antiemetic |
|
Disease Attributes Neurotransmitter Agents Vomiting Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Anesthetics Antiemetics Signs and Symptoms Serotonin Antagonists Promethazine Pathologic Processes Sensory System Agents Therapeutic Uses |
Hypnotics and Sedatives Antipruritics Nausea Ondansetron Dermatologic Agents Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Histamine Agents Anti-Allergic Agents Antipsychotic Agents Anesthetics, Local Pharmacologic Actions Serotonin Agents Histamine Antagonists |