Comparison of the effect of Ondansetron and Granisetron on adult patients referred to the emergency department with nausea and vomiting
Design
Phase 3 clinical trial, with parallel, double-blind, randomized groups
Settings and conduct
Patients Referred to Emergency Department of Imam Khomeini Hospital and Golestan Hospital in Ahvaz with Complaints of nausea and vomitung divide into two equal groups and one group received consciously injected 4mg intravenous Ondansetron and the other group received 1 mg intravenous Granisetron and at times 15, 30 ,45,60,75,90 minutes the VAS method is queried and the results recorded. Subjects were randomly divided into two groups according to the randomized block design method and the study was conducted as a double blind study in this study, the patient and the questioner will be blind.
Participants/Inclusion and exclusion criteria
In this study, all patients with nausea and vomiting and especially patients with nausea and vomiting with vertigo or with gastroenteritis symptoms are admitted to our Emergency Department of Imam Khomeini and Golestan Hospital in Ahvaz. Accompanied by symptoms such as headaches, lateralized symptoms, Uunstable vital signs,patients with no consent to attend or continue treatment , patients with chest pain or ECG changes, patients with Rise ICP symptoms or patients who have received sertonin in the last few days (Such as Fluoxetine, Doxepin, Isomerboxazide, Amitriptyline, etc.) or drugs that stimulate hepatic cytochrome p450 or inhibitors of liver enzymes have used and patients who have consumed grapefruit in the last 24 hours are excluded from our study.
Intervention groups
Patients divide into two equal groups and one group received consciously injected 4mg intravenous Ondansetron and the other group received 1 mg intravenous Granisetron.
Main outcome variables
Nausa and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191007045013N1
Registration date:2020-01-29, 1398/11/09
Registration timing:prospective
Last update:2020-01-29, 1398/11/09
Update count:0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
Akram Shiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3293 5927
Email address
akramshiri1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-04-29, 1399/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Granisetron and Ondansetrone on nausea and vomiting in adult patients referred to the emergency department
Public title
Comparison of Granisetron and Ondansetrone on nausea and vomiting in adult patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nausea and vomiting in adult patients
Exclusion criteria:
Patients with symptoms such as headaches, lateralized symptoms, and unstable vital signs.
Patients who have chest pain or ECG changes.
Patients with symptoms of Rise ICP.
Patients who have been taking sertonin (eg, fluoxetine, doxepin, isomerboxazide, amitriptyline, etc.) in the past few days.
Patients who have used hepatic cytochrome P450 enzyme stimulating drugs or liver enzyme inhibitors in recent days.
Patients who have consumed grapefruit in the past 24 hours
Patient does not consent to attend or continue treatment.
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patient will randomly divide into two groups according to the method of quadratic random block permutation,after sorting patients by computer ,the number of each patient and the drug combination used will be identified and the drugs packaged in packages, only the number on each envelope is that the executor and the nurse are unaware of its contents and the list of medicines is only available to the researcher
Blinding (investigator's opinion)
Double blinded
Blinding description
In this randomized controlled trial, patients are given one of two drugs, Granisetron or Ondansetron, which has no information about the type of drug used by the patient, the injector, and the person examining the effects of the drug. (Patient informed consent to participate in this study and randomized injection of either drug)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-08-04, 1398/05/13
Ethics committee reference number
IR.AJUMS.REC.1398.352
Health conditions studied
1
Description of health condition studied
Nausea and vomiting in patients admitted to the emergency department
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea
Timepoint
15minute ,30minute,45minute,60minute,75 minute,90minute after to take Granisetron or Ondansetron
Method of measurement
Using a visual analogue scaling method where the patient signs a nausea rate on a line measuring 10 cm in length from zero to ten
2
Description
Vomiting
Timepoint
15,30,45,60,75,90minute after to take Granisetron or Ondansetron
Method of measurement
Count the number of vomiting
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group was injected with a conscious consent of 4 mg intravenous Ondansetron(Tehran chemistry company product) in single dose and nausea and vomiting are measure 15,30,45,60,75,90 minutes after to take Ondansetron by visual analogue scale method and questionnaire .
Category
Treatment - Drugs
2
Description
The second intervention group was injected with a conscious consent of 1 mg intravenous Granisetron(Aboureihan company product) in single dose and nausea and vomiting are measure 15,30,45,60,75,90 minutes after to take Granisetron by visual analogue scale method and questionnaire .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeyni hospital
Full name of responsible person
Alivefagh Nematollahi
Street address
Emergency medicine ,Imam Khomeyni hospital ,Azadegan Street ,Ahvaz
Faculty of medicine, Ahvaz Jundishapur university of medical sciences, Golestan Boulevard, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 3815
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alivefagh Nematollahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine ,Imam Khomeini training center,Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 9166
Email
alivefagh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Alivefagh Nematolahy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine, Imam Khomeini Training Center, Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 9166
Email
Alivefagh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Shiri
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
Second floor,NO.205,Panahsazan apartment, Cafi Ave between Adham Ave and Kramikharat Ave, Naderi, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6196654716
Phone
+98 61 3445 3012
Email
Akramshiri1373@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Patient information including nausea and vomiting and associated symptoms that the patient has been referred to, how to use the medication and its effects on patients recorded through the questionnaire, and the patient's informed consent to participate in the study. But the names of study participants are not shared for patient privacy.
When the data will become available and for how long
The start of the access period after the end of the job is the result of the confirmation.
To whom data/document is available
It will be accessible to everyone.
Under which criteria data/document could be used
Use nausea and vomiting or granisetron or ondansetron or emergency keywords to access this study.
From where data/document is obtainable
Email your requests to
alivefagh@yahoo.com.
What processes are involved for a request to access data/document