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 MinAkithisia 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
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