Comparison of the effect of salbutamol spray with its nebulizer in the treatment of acute asthma attacks in children referred to the emergency department of Mofid hospital
Comparison of the effect of salbutamol spray with its nebulizer in the treatment of acute asthma attacks in children referred to the emergency department of Mofid hospital
Design
Clinical trial with control group, with parallel groups in each group 53 patients, without blinding, randomized
Settings and conduct
This clinical trial study will carried out in children aged 6 months to 14 years of old with acute asthma attack referred to Mofid hospital, and 106 patients were randomly assigned to either salbutamol spray or nebulizer. At the time of referral and at minutes 15, 30, 45 and 60, the respiratory distress assessment scale (RDAS) will be determined.There is no blinding in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 6 months and 14 years of old, Having lung wheezing on auscultation, Score > 4 based on the respiratory distress assessment scale. Exclusion criteria: Having bronchopulmonary dysplasia, Having cystic fibrosis, Having congenital heart disease, Unwilling to participate in the study
Intervention groups
Intervention group: Salbutamol Nebulizer 0.15 mg / kg every 20 minutes up to three times
Control group: Salbutamol spray 2 to 8 puffs every 20 minutes up to three times
Main outcome variables
Assessment of respiratory distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181102041527N1
Registration date:2018-12-23, 1397/10/02
Registration timing:retrospective
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Nazanin Farahbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 1631
Email address
nazanin65farahbakhsh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-09, 1394/11/20
Actual recruitment start date
2015-09-23, 1394/07/01
Actual recruitment end date
2016-03-10, 1394/12/20
Trial completion date
2016-03-10, 1394/12/20
Scientific title
Comparison of the effect of salbutamol spray with its nebulizer in the treatment of acute asthma attacks in children referred to the emergency department of Mofid hospital
Public title
The effect of salbutamol nebulizer in the treatment of acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 6 months and 14 years of old
Having lung wheezing on auscultation
Score > 4 based on the respiratory distress assessment scale
Exclusion criteria:
Having bronchopulmonary dysplasia
Having cystic fibrosis
Having congenital heart disease
Unwilling to participate in the study
Age
From 6 months old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
106
Actual sample size reached:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients in two groups of intervention and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence was generated using the free website at http://www.randomization.com.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Daneshjou Blvd, District 1, Tehran, Tehran province
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2015-03-29, 1394/01/09
Ethics committee reference number
IR.SBMU.SM.REC.1394.19
Health conditions studied
1
Description of health condition studied
Asthma attack of children
ICD-10 code
J45.90
ICD-10 code description
Unspecified asthma
Primary outcomes
1
Description
Assessment of respiratory distress
Timepoint
At the time of referral and at minutes 15, 30, 45 and 60
Method of measurement
Respiratory Distress Assessment Scale (RDAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Salbutamol Nebulizer is given as 0.15 mg / kg every 20 minutes up to three times, and then the score for the assessment of respiratory distress is calculated.
Category
Treatment - Drugs
2
Description
Control group: Salbutamol spray 2 to 8 puffs every 20 minutes up to three times is given, and then the score for the assessment of respiratory distress is calculated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid hospital
Full name of responsible person
Seyyed Ahmad TabaTabayi
Street address
Shariati St, District 3, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7029
Email
Ahmadtabatabaii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Deputy of research and technology of Shahid Beheshti University of Medical Sciences
Street address
Daneshjou Blvd, District 1, Tehran, Tehran province
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Farahbakhsh
Position
Fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric department, Mofid children's hospital, Shariati street
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2225 1631
Fax
Email
nazanin65farahbakhsh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Farahbakhsh
Position
Fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric department, Mofid children's hospital, Shariati street
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2225 1631
Fax
Email
nazanin65farahbakhsh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Farahbakhsh
Position
Fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Pediatric department, Mofid children's hospital, Shariati street
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2225 1631
Fax
Email
nazanin65farahbakhsh@sbmu.ac.ir
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
After completion of the study, I will publish it
When the data will become available and for how long
Twelve months
To whom data/document is available
Faculty members and students
Under which criteria data/document could be used
Request through email
From where data/document is obtainable
Email to nazanin26farahbakhsh@yahoo.com
What processes are involved for a request to access data/document