Protocol summary

Study aim
Determining the effect of 5% saline nebulizer with Ventolin compared to 0.9% saline with Ventolin in the treatment of moderate asthma attack in children admitted to the emergency room and pediatric department
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 40 patients. Randomization will be by random number table, and patient checklist will be coded by letters A and B.
Settings and conduct
In this clinical trial, the effect of 5% saline nebulizer along with Ventolin will be compared with 0.9% saline along with Ventolin in the treatment of asthma attacks with moderate severity in children admitted to the emergency ward and the pediatric department of BuAli Hospital in Sari. Patients and treating physician will be blinded.
Participants/Inclusion and exclusion criteria
Children between 1 and 18 years old with a moderate asthma attack and a history of clinically confirmed asthma symptoms (wheezing, shortness of breath, and cough) will be included in the study, and will be excluded if they have heart disease, pneumonia, or rheumatic disease.
Intervention groups
In the intervention group, a vial of salbutamol (Ventolin, salbutamol sulfate 0.15 mg per kg with a minimum dose of 2.5 mg) in 2.5 mL of 5% hypertonic saline (minimum volume of 5 cc) is prescribed for 20 minutes to 3 doses. For the control group, a vial of salbutamol (Ventolin, salbutamol sulfate 0.15 mg per kg with a minimum dose of 2.5 mg) in 2.5 mL of 0.9% normal saline (minimum volume of 5 cc) is prescribed for 20 minutes up to 3 doses.
Main outcome variables
Main outcome variables include improvement in dyspnea, retraction, SPO2 and consciousness, and normal heart rate and respiration rates.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230930059568N1
Registration date: 2023-12-26, 1402/10/05
Registration timing: registered_while_recruiting

Last update: 2023-12-26, 1402/10/05
Update count: 0
Registration date
2023-12-26, 1402/10/05
Registrant information
Name
Abbas Dabbaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
dabbaghzadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of saline nebulizer 5% with Ventolin VS saline nebulizer 0.9% in the management of moderate asthma attack
Public title
Comparison of the effect of saline nebulizer 5% with Ventolin VS saline nebulizer 0.9% in the management of moderate asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 1-18 years Moderate asthma attack Having a history of asthma symptoms (wheezing, shortness of breath and cough) that has been clinically confirmed
Exclusion criteria:
Heart disease Pneumonia Rheumatic disease
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 40 patients with moderate asthma who meet the study’s inclusion criteria are selected. First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 40 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 20 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 40.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and physicians will be blinded so that none of them will know which group they are in.
Placebo
Not 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 Sciences
Street address
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2023-09-23, 1402/07/01
Ethics committee reference number
IR.MAZUMS.REC.1402.424

Health conditions studied

1

Description of health condition studied
Moderate Asthma
ICD-10 code
J45.40
ICD-10 code description
Moderate persistent asthma, uncomplicated

Primary outcomes

1

Description
Improvement of Dyspnea
Timepoint
0, 20, 40 and 60 minutes following treatment
Method of measurement
Observation

2

Description
Retraction
Timepoint
0, 20, 40 and 60 minutes following treatment
Method of measurement
Observation

3

Description
SPO2
Timepoint
0, 20, 40 and 60 minutes following treatment
Method of measurement
Pals oxymeter

4

Description
Heart rate
Timepoint
0, 20, 40 and 60 minutes following treatment
Method of measurement
Measuring Heart rate

5

Description
Respiratory rate
Timepoint
0, 20, 40 and 60 minutes following treatment
Method of measurement
Measuring respiratory rate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, a vial of salbutamol (Ventolin, salbutamol sulfate 0.15 mg per kg with a minimum dose of 2.5 mg) in 2.5 mL of 5% hypertonic saline (minimum volume of 5 cc) is prescribed for 20 minutes to 3 doses.
Category
Treatment - Drugs

2

Description
Control group: For the control group, a vial of salbutamol (Ventolin, salbutamol sulfate 0.15 mg per kg with a minimum dose of 2.5 mg) in 2.5 mL of 0.9% normal saline (minimum volume of 5 cc) is prescribed for 20 minutes up to 3 doses.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Buali Hospital
Full name of responsible person
Dr. Abbas Dabbaghzadeh
Street address
Bu-Ali Sina Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 911 351 2452
Email
dabbaghzadeh@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3448 4800
Email
p.ebrahimnezhad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Dr. Abbas Dabbaghzadeh
Position
Assistant professor of clinical allergy and immunology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Infectious Diseases Research Center, Buali hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
dabbaghzadeh@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Abbas Dabbaghzadeh
Position
Assistant professor of clinical allergy and immunology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Infectious Diseases Research Center, Buali hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
dabbaghzadeh@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Sahar Yousefi
Position
Pediatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric Infectious Diseases Research Center, Buali hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
fatima.hzade@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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data is accessible
When the data will become available and for how long
Starting in March 2025
To whom data/document is available
Everyone
Under which criteria data/document could be used
Systematic review articles
From where data/document is obtainable
Contact Dr. Abbas Dabbaghzadeh: dabbaghzadeh@mazums.ac.ir
What processes are involved for a request to access data/document
After contact, information is sent within a few days
Comments
Loading...