Comparison of the effectiveness of magnesium sulfate nebulizer and ipratropium bromide in children with asthma attacks admitted to Masih Deneshvari Hospital in Tehran in 1402
of the effectiveness of magnesium sulfate nebulizer and ipratropium bromide in children with asthma attacks admitted to Masih Deneshvari Hospital in Tehran in 1402
Design
Two parallel groups of a blind strain, phase 3, non-randomized on 50 patients, in which 25 patients are prescribed magnesium sulfate nebulizer and 25 patients are prescribed ipratropium bromide nebulizer.
Settings and conduct
Patients with asthma attacks in Masih Deneshvari Hospital in Tehran after receiving three doses of salbutamol nebulizer and no improvement, for 25 patients magnesium sulfate (magnesium sulfate 50%, 0.3 ml (150 mg) diluted with 2.2 ml of distilled water) and ipratropium bromide nebulizer is prescribed for other 25 patients.The respiratory rate and heart rate and pulse oximetry in the intervals before administration and 30, 60 and 120 minutes after receiving the drug will be recorded , and the patients are also examined in these intervals in terms of the presence of wheezing in lung auscultation.If necessary, for each of the patients, if there is no improvement, further treatments and measures will be performed.Patients do not know which type of drug they received because the form and form of both drugs are the same and the study is blinded.
Participants/Inclusion and exclusion criteria
Among the patients aged 2 to 18 years with an asthma attack who were hospitalized after receiving three doses of salbutamol nebulizer and there was no improvement in stable clinical conditions, they were included in the study.
Patients with immunodeficiency and underlying disease are excluded from the study.
Intervention groups
Intervention group 1: magnesium sulfate nebulizer. Intervention group 2: ipratropium bromide nebulizer.
Comparison of the effectiveness of magnesium sulfate nebulizer and ipratropium bromide in children with asthma attacks admitted to Masih Deneshvari Hospital in Tehran in 1402
Public title
Comparing the effect of magnesium sulfate nebulizer and ipratropium bromide nebulizer in children with asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with asthma attack
Over 2 years to 18 years
After receiving primary asthma attack treatment (salbutamol)
Stable clinical conditions
Exclusion criteria:
Immunodeficiency
Underlying disease
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
After obtaining consent from the patient or parents and obtaining permission from the ethics committee, the procedure is explained to the patients or parents, which includes comparing the effectiveness of magnesium sulfate nebulizer and ipratropium bromide, both of which are approved for the treatment of asthma attacks. Both drugs are in liquid and colorless form, and the patient does not know which drug he has received.
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
Tehran Province, Tehran, District 1, Daneshjou Blvd
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.SBMU.MSP.REC.1401.691
Health conditions studied
1
Description of health condition studied
Magnesium sulfate nebulizer in asthma attack
ICD-10 code
J45.51
ICD-10 code description
Severe persistent asthma with (acute) exacerbation
Primary outcomes
1
Description
Respiratory rate
Timepoint
Intervals before administration and 30, 60 and 120 minutes after receiving the drug
Method of measurement
Lung examination
2
Description
Heart rate
Timepoint
Intervals before administration and 30, 60 and 120 minutes after receiving the drug
Method of measurement
Cardiac examination
3
Description
Blood oxygen saturation percentage
Timepoint
Intervals before administration and 30, 60 and 120 minutes after receiving the drug
Method of measurement
Pulse oximetry device
4
Description
Wheezing
Timepoint
Intervals before administration and 30, 60 and 120 minutes after receiving the drug
Method of measurement
Lung examination with a stethoscope
5
Description
Duration of symptoms (less than or more than 6 hours)
Timepoint
Intervals before administration and 30, 60 and 120 minutes after receiving the drug
Method of measurement
Physical examination
6
Description
Treatments after nebulizer administration
Timepoint
After repeated examinations
Method of measurement
General condition of the patient
Secondary outcomes
empty
Intervention groups
1
Description
ّFirst intervention group: Magnesium sulfate nebulizer (magnesium sulfate 50%, 0.3 mL (150 mg) diluted with 2.2 mL of distilled water)
Category
Treatment - Drugs
2
Description
Second intervention group: Ipratropium bromide nebulizer based on standard dose for age according to GINA 2022 guidelines
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Deneshvari Hospital, Tehran
Full name of responsible person
Niloofar Esfahanian
Street address
Shahid Bahonar St. (Niavaran) - Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
pr.nritld@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Building No. 2 - Fifth Floor-, Yemen Street - Shahid Arabi Street -Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
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
Niloofar Esfahanian
Position
Pediatric Pulmonology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 42, Qeytaryeh 12 Meteri St-Tehran
City
Tehran
Province
Tehran
Postal code
1938653854
Phone
+98 21 2269 0913
Email
n.esfahanian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Esfahanian
Position
Pediatric Pulmonology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 42, Qeytarieh 12 Meteri St- Tehran
City
Tehran
Province
Tehran
Postal code
1938653854
Phone
+98 21 2269 0913
Email
n.esfahanian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Esfahanian
Position
Pediatric Pulmonology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 42, Qeytarieh 12 Meteri St-Tehran
City
Tehran
Province
Tehran
Postal code
1938653854
Phone
+98 21 2269 0913
Email
n.esfahanian@gmail.com
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