Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Study Overview
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Brief Summary
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This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Detailed Description
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Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date. Inclusion Criteria: Patients presenting to the ED with at least one of the following nausea vomiting documented in the ED

Official Title
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Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Conditions
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Nausea and Vomiting

Intervention / Treatment
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* Drug: Prochlorperazine
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting to the ED with at least one of the following Nausea Vomiting documented in the ED Exclusion Criteria: Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide Patients with missed last menstrual period Pregnancy Age < 18 years old Treatment with antineoplastic agents within 7 days prior to randomization Irritable bowel syndrome Gastroparesis Suspected gastrointestinal bleed Suspected intestinal obstruction Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease) Traumatic brain injury upon admission to ED Intracranial hemorrhage upon admission to ED Patients unable to read, write or communicate in the English language Patients leaving the ED against medical advice

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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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prochlorperazine<br>Patients receiving Prochlorperazine 10mg IV | Drug: Prochlorperazine<br>* Patients receiving Prochlorperazine<br>|
| Active Comparator: Ondansetron<br>Patient receiving Ondansetron 4mg IV | Drug: Ondansetron<br>* Patients receiving Ondansetron<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vomiting at 0 to 120 Min. |  | 0 to 120 minutes after receiving medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea at 0 to 120 Min | 100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea | 0 to 120 minutes after receiving medication | 
| Akithisia at 0 to 120 Min |  | 0 to 120 min after receiving medication |