A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

Study Overview
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Brief Summary
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This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Ondansetron
* Drug: promethazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ondansetron|nan|
|Drug: promethazine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in nausea on a VAS. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sedation on a VAS |  |  | 
| Change in anxiety on a VAS |  |  | 
| Need for rescue medication at 30 minutes |  |  | 
| Patient satisfaction at follow-up |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, vomiting, antiemetic