Comparison of Metoclopramide and Ondansetron in controlling nausea in adult patients
Design
Triple controlled parallel groups ,double blind, clinical trials with frequent measurements
Settings and conduct
Patients referred to Emergency of Imam Khomeini Hospital with a complaint of nausea are assigned randomly to one of three treatment groups.
These patients will not know what group they are in.
The pharmacist, without the knowledge of the investigator, will encode the medications.So, the investigator, doctor and nurse will also be unaware of the name of the drug they received
Participants/Inclusion and exclusion criteria
Participants Inclusion criteria:over 18 years of age, conscious, need to get an anti-nausea medicine as directed by the doctor, the severity of nausea greater than 40 mm in a ruler scale such as the Visual Analog Scale (VMS) analogue scale (100 mm).
Participants exclusion criteria:unstable hemodynamics (systolic blood pressure less than 90mmHg), history of allergies to any of the drugs studied, pregnancy, receiving an anti-nausea medicine in the last 24 hours, any disability (physical and mental) and patient's unwillingness.
Intervention groups
The intervention groups consisted of three groups of Ondansetron therapy, Metoclopramide and Placebo, normal saline
Main outcome variables
Severity of nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180717040509N1
Registration date:2018-08-02, 1397/05/11
Registration timing:retrospective
Last update:2018-08-02, 1397/05/11
Update count:0
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Mahboubeh Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3321 7982
Email address
m.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-09-21, 1395/06/31
Actual recruitment start date
2016-01-21, 1394/11/01
Actual recruitment end date
2016-09-21, 1395/06/31
Trial completion date
empty
Scientific title
A Comparison of metoclopramide with Ondansetron for Treating Nausea in Adult Patient
Public title
Comparison of metoclopramide with Ondansetron for Treating Nausea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with Nausea sign
Exclusion criteria:
Age under 18 years
Pregnant patients
Patients with mental and physical disabilities
Patients with a history of allergy to study drugs
Patients with systolic blood pressure less than 90mmHg
Receive an anti-nausea medicine in the last 24 hours
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization, block
Random unit: Individual
Randomization Tool: Table of Random Numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are assigned Simple randomization to one of the three treatment groups by department staff. So, patients will not know what group they are in. The pharmacist of the study, without the knowledge of the investigator,doctor and nurse will code the drugs (codes A, B, C). In this way, the investigator, doctor and nurse will also be unaware of the name of the drug they received
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mazandaran university of medical science
Street address
Moallem Square
City
Sari
Province
Mazandaran
Postal code
4817844818
Approval date
2018-01-09, 1396/10/19
Ethics committee reference number
IR.MAZUMS.REC.1395.1720
Health conditions studied
1
Description of health condition studied
Nause
ICD-10 code
R11.0
ICD-10 code description
Nausea
Primary outcomes
1
Description
Severity of nausea based on Visual َAnalog Scale
Timepoint
At the beginning of the study (before the injection) and 30 minutes after the injection of the drug
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
ّFirst Intervention group: Ondansetron 4mg / 2ml, manufactured by Tehran Chemistry Co., is prepared in 2ml syringes. Drug injections will be given by a nurse with the help of angiogenesis in the peripheral blood vessels of the patient.
Category
Treatment - Drugs
2
Description
Second Intervention group: Methoclopramide 10mg / 2ml drug manufactured by Tehran Chemistry Co. is prepared in 2 ml syringes. Drug injections will be given by a nurse with the help of angiogenesis in the peripheral blood vessels of the patient.
Category
Treatment - Drugs
3
Description
Control group: The normal saline of the placebo is prepared in 2 ml syringes. The injection will be done by a nurse with the help of angiogenesis located in the peripheral vascular of the patient.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Fatemeh Jahaniyan
Street address
Emam Khomeini Haospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
sheilaml442@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Vice Chanceller for Research, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Jahaniyan
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11221700
Email
sheilaml442@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Jahaniyan
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
sheilaml442@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahboubeh Eslami
Position
Employee
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Moalem Square, Vice Chanceller for Research
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Fax
Email
m.eslami@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available