Comparison of the effect of ondansetron and chlorpheniramine in controlling nausea in emergency patients
Design
A clinical trial with a control group with parallel and double blind groups, phase 3 on 195 patients in 3 groups that each group contains 65 patients(ondansetron,chlorpheniramine,placebo).
Settings and conduct
The study was conducted in the emergency room of Imam, Golestan and Razi hospitals in Ahvaz.
The randomization method will be in the form of blocked randomization ,the number of people in each group is 65 according to statistical studies. the drugs will be placed in envelopes and each envelope will be given a number, so that the person administering the injection will not be aware of the contents of the envelope before opening it.
Participants/Inclusion and exclusion criteria
Our study will be conducted on patients who refer to the emergency department who complain of nausea.
Exclusion criteria include trauma, especially to the abdomen, persistent vomiting 1 hour after hospitalization, alcohol consumption, unstable hemodynamics, pregnancy, and drug sensitivity to chlorpheniramine and ondansetron. The criteria for inclusion is the consent of patients who are willing to participate in the project and be at least 18 years old. All patients who have stable hemodynamics but need intravenous fluids will undergo intravenous fluid therapy before receiving the drug.
Intervention groups
Subjects received ondansetron (4mg/2ml) by slow intravenous injection, chlorpheniramine by slow intravenous injection (10mg/1ml), and placebo(4 ml normal saline)
Main outcome variables
nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230726058930N4
Registration date:2024-05-11, 1403/02/22
Registration timing:registered_while_recruiting
Last update:2024-05-11, 1403/02/22
Update count:0
Registration date
2024-05-11, 1403/02/22
Registrant information
Name
Ali Vefagh Nematollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3367 5436
Email address
vefagh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-24, 1403/02/05
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effect of ondansetron And Chlorpheniramine in controlling nausea in adults in emergency department
Public title
Comparison of Effect of ondansetron And Chlorpheniramine in controlling nausea in adults in emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of patients to participate in the trial
to be at least 18 years old
The patient complains of nausea
Exclusion criteria:
trauma(specially abdomen)
continuous vomiting which persists 1 hour after admission
alcohol consumption
unstable hemodynamic
history of allergy to ondansetron or Chlorpheniramine
pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
195
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization happens in drugs and it will be in the form of blocked randomization. in such a way that the drugs are placed in separate envelopes, each of which is assigned a number, and then, while the person responsible for the injection does not know about the contents of the envelope, it is given to the patient who has the conditions to participate in the study .People are not categorized before opening the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is conducted in a double-blind manner, which means that neither the patient nor the nurse knows the contents of the envelope before opening the envelope. Due to the different shape of the vials, each vial is placed in an envelope and a number will be assigned to it. The project manager who is responsible for the injection should be unaware of the contents of the envelope.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of Ahbaz Jundishapur University of Medical Sciences
Street address
No. 385, Oribehesht St. Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135833843
Approval date
2024-04-07, 1403/01/19
Ethics committee reference number
IR.AJUMS.REC.1403.005
Health conditions studied
1
Description of health condition studied
Nausea in emergency room patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The degree of change in the patient's nausea based on a scale from 1 to 10 in zero, 20 and 60 minutes
Timepoint
At the time of injection, 20 minutes and 60 minutes after
Method of measurement
Based on the visual analog scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients, ondansetron is administered intravenously at a dose of 4 mg/2 ml
Category
Treatment - Drugs
2
Description
Intervention group: This group of patients receives 4 ml of normal saline as a placebo
Category
Placebo
3
Description
Intervention group: This group of patients receives chlorpheniramine intravenously at a dose of 10 mg/ml
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeyni Hospital
Full name of responsible person
Ali Vefagh Nematollahi
Street address
Imam Khomeini Medical Education Center Ahvaz- Azadegan St.- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ali Vefagh Nematollahi
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
3
Recruitment center
Name of recruitment center
razi hospital
Full name of responsible person
Ali Vefagh Nematollahi
Street address
razi hospital, felestin street,amaniye,ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 3050
Email
vefagh.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
Ahvaz Jondishapur University of Medical Sciences ٫ golestam highway,ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
aduaum@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
Ali Vefagh nematollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Vefagh nematollahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Vefagh nematollahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department Office- Golestan Hospital- Golestan (Farvardin St.)- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3374 3099
Email
vefagh.a@ajums.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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available