Diagnostic criteria of asthma is according to GINA with respect to history - clinical examination and, if necessary, respiratory function tests and moderate to severe asthma criteria is according to GINA criteria. Before, 30,60 and 90 minutes after treatment, respiratory index score and PEFR will be measured by peak flow meter (Germany, model REF HS755EU) for each patient and age and gender of the patients will be recorded.
Then salbutamol+magnesium sulfate nebulizer and salbutamol+normal saline nebulizer will be done for each patient with a Jet nebulizer from Omeron company at 0, 30,60 and 90 minutes.
Magnesium sulfate 7.5% (isotonic) and 15mg/kg Salbutamol will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110024396N3
Registration date:2012-04-16, 1391/01/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-16, 1391/01/28
Registrant information
Name
Iraj Mohammadzadeh
Name of organization / entity
Non-communicable pediatric diseases research center
Country
Iran (Islamic Republic of)
Phone
+98 11 1324 2151
Email address
i.mohammadzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-09-21, 1391/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of salbutamol and magnesium sulfate nebulizer compared with salbutamol and normal saline nebulizer in the treatment of acute asthma attack
Public title
Effect of salbutamol and magnesium sulfate nebulizer compared with salbutamol and normal saline nebulizer in the treatment of acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 5-14 years, suffering from moderate or severe asthma with asthma attack
Exclusion criteria:
History of steroid therapy, theophylline, Atrovent in the past three days; a history of chronic diseases such as Bronchopulmonary dysplasia, cystic fibrosis and known allergy to magnesium sulphate and salbutamol and the inability to perform peak flow meter
Age
From 5 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol university of medical sciences
Street address
Babol university of medical sciences
City
Babol
Postal code
Approval date
2011-01-21, 1389/11/01
Ethics committee reference number
4618 /30/پ ژ
Health conditions studied
1
Description of health condition studied
Pediatric asthma
ICD-10 code
J45.9
ICD-10 code description
Asthma, unspecified
Primary outcomes
1
Description
Increase of PEFR (Peak Expiratory Flow Rate)
Timepoint
0,30,60 and 90 minutes after entrance
Method of measurement
With peak flow meter
Secondary outcomes
1
Description
Pulmonary index
Timepoint
At 0, 30, 60 , 90th minute
Method of measurement
By using Pulmonary index table
Intervention groups
1
Description
At first the asthma is diagnosed according to GINA criteria and history, clinical examination and if possible, respiratory function tests and will be categorized as moderate to severe asthma.
before treatment and 30, 60 and 90 minutes after that, respiratory index score and PEFR will be measured by a peak flow meter for each patient and age and gender will be recorded.
Then salbotamol+magnesium sulfate nebulizer at 0,30,60,90 minutes will be nebulized.
Magnesium sulfate 7.5% (isotonic) and 0.15 mg/kg salbotamol will be used
Category
Treatment - Drugs
2
Description
At first the asthma is diagnosed according to GINA criteria and history, clinical examination and if possible, respiratory function tests and will be categorized as moderate to severe asthma.
before treatment and 30, 60 and 90 minutes after that, respiratory index score and PEFR will be measured by a peak flow meter for each patient and age and gender will be recorded.
Then salbotamol+normal saline nebulizer at 0,30,60,90 minutes will be nebulized.
Magnesium sulfate 7.5% (isotonic) and 0.15 mg/kg salbotamol will be used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkola Children's Hospital
Full name of responsible person
Iraj Mohammadzadeh, MD
Street address
Babol-Amirkola- Amirkola Children's Hospital
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Amrollah Mostafazadeh
Street address
Babol university of medical sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Non-Communicable Pediatric Diseases Research Center
Full name of responsible person
Iraj Mohammadzadeh, MD
Position
Clinical asthm and immunology superspecialist
Other areas of specialty/work
Street address
Babol-Amirkola- Amirkola Children's Hospital
City
Babol
Postal code
Phone
+98 911 111 2228
Fax
+98 11 1324 6963
Email
i.mohammadzadeh@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Non-Communicable Pediatric Diseases Research Center
Full name of responsible person
Iraj Mohammadzadeh
Position
Associate professor
Other areas of specialty/work
Street address
Babol-Amirkola- Amirkola Children's Hospital
City
Babol
Postal code
Phone
+98 911 111 2228
Fax
+98 11 1324 6963
Email
i.mohammadzadeh@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Science
Full name of responsible person
Mohsen Mohammadi
Position
MD, Resident of Pediatrics
Other areas of specialty/work
Street address
Babol-Amirkola- Amirkola Children's Hospital
City
Babol
Postal code
Phone
+98 911 126 3074
Fax
+98 11 1324 6963
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)