Back to resultsOndansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
Primary Purpose
Nausea and Vomiting
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prochlorperazine
Ondansetron
Sponsored by
About this trial
This is an interventional treatment trial for Nausea and Vomiting
Eligibility 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
Sites / Locations
- Grady Hospital
- Grady Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Prochlorperazine
Ondansetron
Arm Description
Patients receiving Prochlorperazine 10mg IV
Patient receiving Ondansetron 4mg IV
Outcomes
Primary Outcome Measures
Vomiting at 0 to 120 Min.
Secondary Outcome Measures
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
Akithisia at 0 to 120 Min
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00590317
Brief Title
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
Official Title
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prochlorperazine
Arm Type
Active Comparator
Arm Description
Patients receiving Prochlorperazine 10mg IV
Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Description
Patient receiving Ondansetron 4mg IV
Intervention Type
Drug
Intervention Name(s)
Prochlorperazine
Intervention Description
Patients receiving Prochlorperazine
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Patients receiving Ondansetron
Primary Outcome Measure Information:
Title
Vomiting at 0 to 120 Min.
Time Frame
0 to 120 minutes after receiving medication
Secondary Outcome Measure Information:
Title
Nausea at 0 to 120 Min
Description
100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea
Time Frame
0 to 120 minutes after receiving medication
Title
Akithisia at 0 to 120 Min
Time Frame
0 to 120 min after receiving medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Patka, PharmD
Organizational Affiliation
Grady Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel T Wu, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
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