Comparison of the effect of injectable adrenaline and nebulizer in children with acute asthma attack who did not respond to standard treatments.
Design
This study is a randomized, single-blind clinical trial.
Considering the first error of 5% and the power of 80%, and including the dropout, the number of 33 people and a total of 66 people have been considered.
A non-random sampling method was chosen after obtaining written informed consent
Settings and conduct
Children suffering from an acute attack referred to the emergency room of Akbar, Qaim or Dr. Sheikh Children's Hospitals, who did not respond to the initial stages of standard asthma treatment including bronchodilator oxygen, Atrovent, and injectable corticosteroids at appropriate doses, and due to the persistence of respiratory symptoms, the need to use Complementary drugs such as magnesium sulfate or adrenaline are administered under the subcutaneous injection of epinephrine or nebulized epinephrine. Two ampoules of epinephrine will be added to the appropriate volume for nebulization. It is done in the time interval before the visit and one hour after receiving subcutaneous epinephrine or epinephrine nebulization.
Participants/Inclusion and exclusion criteria
Children aged 2 to 14 years; children with severe and resistant asthma attacks that have not responded to standard asthma treatment in the early stages including: bronchodilator oxygen, Atrovent and intravenous corticosteroids.
Intervention groups
Children aged 2 to 14 years with severe asthma attacks who have not responded to standard treatments are compared with two methods of injectable adrenaline and nebulizer.
Main outcome variables
Number of breaths per minute according to age, vise (inhaler) vise expiratory, ratio of inhalation to exhalation, use of secondary muscles of respiration, oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230606058389N1
Registration date:2023-07-10, 1402/04/19
Registration timing:registered_while_recruiting
Last update:2023-07-10, 1402/04/19
Update count:0
Registration date
2023-07-10, 1402/04/19
Registrant information
Name
Mohammad Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 879 4426
Email address
ghasemim12@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of epinephrine nebulizer with subcutaneous injection in patients with acute asthma attack: a randomized clinical trial
Public title
The effect of epinephrine nebulizer with subcutaneous injection in patients with acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with acute asthma attacks referred to the emergency of Akbar's children, Qaem or Dr. Sheikh hospitals who have not responded to the initial stages of standard asthma treatment, including bronchodilator oxygen, Atrovent, and injectable corticosteroids with appropriate doses.
Exclusion criteria:
Children with asthma with conventional treatment response
Children over 14 years old
Children with asthma due to another side effect
Age
From 2 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
Exactly equal number of participants are included in the intervention and control group at consecutive but equal time intervals. And blocks of four will be used.
The sequences will be placed in the envelopes in the package. The appearance of the envelopes is such that their contents cannot be seen from the outside. Then, one of the envelopes will be opened for each patient entered into the plan and based on the contents of the envelope, the patient will be entered into one of the control or intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The sequences will be placed in the envelopes in the package. The appearance of the envelopes is such that their contents cannot be seen from outside. Then, one of the envelopes will be opened (in order) for each patient entered into the plan and based on the contents of the envelope, the patient will be entered into one of the control or intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad, Daneshgah Street, next to Hoizeh Cinema, Qorshi Building, Research and Technology Vice-Chancellor
City
Mashahd
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-04-24, 1400/02/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.244
Health conditions studied
1
Description of health condition studied
Status asthma
ICD-10 code
J45.902
ICD-10 code description
Unspecified asthma with status asthmaticus
Primary outcomes
1
Description
Number of breaths per minute according to age,
Timepoint
The time interval before the visit and one hour after receiving subcutaneous epinephrine or epinephrine bolus. Patients will be visited and examined by the on-call resident during their hospitalization.
Method of measurement
Subcutaneous injection of epinephrine with a dose of 0.01 cc of 1.1000 solution or nebulization of epinephrine in the form of nebulization of two ampoules of epinephrine 1.1000 which will be placed after adding normal saline to the appropriate volume for nebulization.
2
Description
Expiratory - inspiratory wheezing
Timepoint
The time interval before the visit and one hour after receiving subcutaneous epinephrine or epinephrine bolus. Patients will be visited and examined by the on-call resident during their hospitalization.
Method of measurement
Subcutaneous injection of epinephrine with a dose of 0.01 cc of 1.1000 solution or nebulization of epinephrine in the form of nebulization of two ampoules of epinephrine 1.1000 which will be placed after adding normal saline to the appropriate volume for nebulization.
3
Description
Use of respiratory secondary muscles
Timepoint
The time interval before the visit and one hour after receiving subcutaneous epinephrine or epinephrine bolus. Patients will be visited and examined by the on-call resident during their hospitalization.
Method of measurement
Subcutaneous injection of epinephrine with a dose of 0.01 cc of 1.1000 solution or nebulization of epinephrine in the form of nebulization of two ampoules of epinephrine 1.1000 which will be placed after adding normal saline to the appropriate volume for nebulization.
4
Description
Oxygen saturation according to the Pulmonary Index score table
Timepoint
The time interval before the visit and one hour after receiving subcutaneous epinephrine or epinephrine bolus. Patients will be visited and examined by the on-call resident during their hospitalization.
Method of measurement
The treatment steps for asthma symptoms will be carefully checked and recorded according to the pulmonary index score table. Then the symptoms will be checked until the end of the complete recovery and the time to reach this condition for both groups will be recorded in the checklist prepared for this purpose.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children with an acute asthma attack that has not responded to standard treatments. Children with an acute attack referred to the emergency room of Akbar, Qaim or Sheikh Children's Hospitals who have not responded to the initial stages of standard asthma treatment including bronchodilator oxygen, Atrovent, and injectable corticosteroids with appropriate doses, and due to the persistence of respiratory symptoms and wheezing Inclusion criteria are included in the treatment process. After obtaining written informed consent from parents or legal guardians and under subcutaneous injection of epinephrine with a dose of 0.01 cc of 1.1000 solution or epinephrine nebulization in the form of nebulization of two ampoules of epinephrine 1.1000 which after adding normal saline reached the appropriate volume for nebulization will be placed. The procedures will be performed under the supervision of the resident guard of the hospital and according to the standard instructions, which will be performed between the time of visit and one hour after receiving subcutaneous epinephrine. The stages of recovery of asthma symptoms will be checked and recorded according to the pulmonary index score table. Then the symptoms will be checked until the end of the complete recovery and the time to reach this condition for both groups will be recorded in the checklist prepared for this purpose.
Category
Treatment - Drugs
2
Description
Control group: Children with an acute attack of severe asthma and resistant to the standard early stages of asthma treatment (including: oxygen therapy, nebulized bronchodilator, Atrovent, injectable corticosteroids) treated with standard asthma treatment and subcutaneous epinephrine ampoules 1.1000 with dosage CC 0.01. The continuation of the treatment process, such as the intervention group, will be carefully checked and recorded by the hospital resident and relevant specialist at intervals upon entering the hospital and according to the table.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Seyed Javad Seyedi
Street address
Blvd- Kaveh 14
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 910 171 6090
Email
ghasemim12@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
University Street - next to Hoizeh Cinema - Qurashi Building - Research and Technology Vice-Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 910 171 6090
Email
Mobinmdl94@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Javad Seyedi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar hospital, Kaveh-14 blvd.
City
Mashahd
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 910 171 6090
Email
mobinmdl94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Javad Seyedi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar hospital, Kaveh-14 blvd.
City
Mashahd
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 910 171 6090
Email
mobinmdl94@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Javad Seyedi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar hospital, Kaveh-14 blvd.
City
Mashahd
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 910 171 6090
Email
mobinmdl94@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After the end of the research, the data obtained from the results and the main consequence or consequences after de-identification can be published.
When the data will become available and for how long
The start of the access period 6 to 8 months after the end of the study
To whom data/document is available
All the people who conduct treatment and intervention in the field of research or policy making can use the data of this research.
Under which criteria data/document could be used
Approval or obtaining permission from legal centers or responsible for research
From where data/document is obtainable
Applicants can contact the email of the corresponding author of the research.
What processes are involved for a request to access data/document
The applicant's response will be reviewed as soon as possible. This time lasts about a week.