Comparison of the effect of dexamethasone with prednisolone in controlling asthma attacks in children aged 2-10 years in pediatric clinics in Qom in 2018-19
Comparison of the effect of dexamethasone with prednisone in the treatment of acute asthma exacerbation
Design
Clinical trial with parallel groups, one-way blind, without randomization, on 100 patients.
Settings and conduct
This research was conducted by clinical trial in the office and clinic of Ayatollah Golpayegani Hospital in Qom in 2018 - 2019. In this study; out of the total number of patients with acute asthma attack, 100 eligible patients were selected and studied.
The procedure was as follows: at first, patients with acute asthma were identified by a pediatrician according to GINA criteria after selecting the medication regimen and performing other measures; Parents were given the necessary explanations about the purpose of the research and if they wish and consent to participate in the research; Questionnaires were completed under the supervision of the researcher and with the necessary explanations. The researcher followed up by phone on the seventh day of treatment; she complete the questionnaire questions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 2 to 10 years old; definitive asthma according to GINA criteria; patients with refractory asthma according to GINA criteria.
Exclusion criteria: having a medical condition that affects outcomes such as viral or bacterial infections of the airways; taking antibiotics in the last month; lack of compliance with medication; patient reluctance.
Intervention groups
In this clinical trial study, 100 patients with asthma were selected and divided into two groups.
Both groups were approved for routine treatment with salbutamol and oxygen spray and
For the first group, dexamethasone is prescribed in two doses of 0.6 mg / kg / dose and for the second group, oral prednisone at a dose of 1.5 mg / kg / day is prescribed for 5 days.
Main outcome variables
Control of asthma attack with GINA and VAS criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201005048939N1
Registration date:2020-10-20, 1399/07/29
Registration timing:retrospective
Last update:2020-10-20, 1399/07/29
Update count:0
Registration date
2020-10-20, 1399/07/29
Registrant information
Name
Hodasadat Safavisohi
Name of organization / entity
Islamic Azad University of Qom
Country
Iran (Islamic Republic of)
Phone
+98 25 3292 9647
Email address
h.sss.3.smiley@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-01-05, 1397/10/15
Trial completion date
2019-01-12, 1397/10/22
Scientific title
Comparison of the effect of dexamethasone with prednisolone in controlling asthma attacks in children aged 2-10 years in pediatric clinics in Qom in 2018-19
Public title
Comparison of the effect of dexamethasone with prednisolone in controlling asthma attacks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 2 to 10 years old
Definitive asthma according to GINA criteria
Patients with refractory asthma according to GINA criteria
Exclusion criteria:
Having a medical condition that affects outcomes such as viral or bacterial infections of the airways
Taking antibiotics in the last month
Lack of compliance with medication
Patient reluctance
Age
From 2 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study samples were children and their parents did not know about the medication regimen chosen by the doctor
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Pharmacy and Pharmaceutical Sciences, Islamic Azad University of
Street address
Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.IAU.PS.REC.1399.052
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.4
ICD-10 code description
Moderate persistent asthma with status asthmaticus
Primary outcomes
1
Description
Control asthma attack
Timepoint
At the beginning of the study and day 7 after starting treatment
Method of measurement
Visual Analogue Scale, Global Initiative for Asthma
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group were treated with dexamethasone at a dose of 0.6 mg / kg (max = 16 mg / dose) with intramuscular method for two days. Salbutamol and oxygen sprays were performed for all patients at the time of referral.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group underwent oral prednisolone at a dose of 1.5 mg / kg / day (max = 60 mg / day) for 5 days. Salbutamol and oxygen sprays were performed for all patients at the time of referral.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Clinic of Ayatollah Golpayegani Hospital, Qom
Full name of responsible person
Hoda Safavi
Street address
Motahhari Square, Rahbar Street
City
Qom
Province
Ghoum
Postal code
3714963744
Phone
+98 25 3616 1111
Email
h.golpayegani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Qolam Reaza Najafi
Street address
Pardisan, University Blvd.
City
Qom
Province
Ghoum
Postal code
3749113191
Phone
+98 25 3280 8080
Email
q_najafi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mohmad Javad Qasem zade
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Islamic Azad University, next to Social Security Insurance, 15 Khordad Blvd., Shah Seyed Ali Square
City
Qom
Province
Ghoum
Postal code
3719463744
Phone
+98 25 3778 0001
Email
qasemzade.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hoda Sadat Safavid
Position
physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad University, next to Social Security Insurance, 15 Khordad Blvd., Shah Seyed Ali Square
City
Qom
Province
Ghoum
Postal code
3714963744
Phone
+98 25 3778 0001
Email
H.sss.3.smiley@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hoda Sadat Safavid
Position
physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Islamic Azad University, next to Social Security Insurance, 15 Khordad Blvd., Shah Seyed Ali Square
City
Qom
Province
Ghoum
Postal code
3714963744
Phone
+98 25 3778 0001
Email
H.sss.3.smiley@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
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use to insert in the article with reference
From where data/document is obtainable
Islamic Azad University of Qom
What processes are involved for a request to access data/document
By inserting the request in the email and replying after viewing the email