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Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea and Vomiting

Intervention: Prochlorperazine (Drug); Ondansetron (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
John Patka, PharmD, Principal Investigator, Affiliation: Grady Memorial Hospital
Daniel T Wu, MD, Principal Investigator, Affiliation: Emory University

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Vomiting at 0 to 120 Min.

Secondary outcome:

Nausea at 0 to 120 Min

Akithisia at 0 to 120 Min

Detailed description: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Grady Hospital, Atlanta, Georgia 30303, United States

Grady Memorial Hospital, Atlanta, Georgia, United States

Additional Information

Starting date: March 2005
Last updated: April 23, 2014

Page last updated: August 23, 2015

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