Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-09-30

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.

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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

Conditions

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Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prochlorperazine

Patients receiving Prochlorperazine 10mg IV

Group Type ACTIVE_COMPARATOR

Prochlorperazine

Intervention Type DRUG

Patients receiving Prochlorperazine

Ondansetron

Patient receiving Ondansetron 4mg IV

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

Patients receiving Ondansetron

Interventions

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Prochlorperazine

Patients receiving Prochlorperazine

Intervention Type DRUG

Ondansetron

Patients receiving Ondansetron

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes