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IRCT20230606058389N1 IRCT 2023-07-10 Mashhad University of Medical Sciences The effect of epinephrine nebulizer with subcutaneous injection in patients with acute asthma attack Comparison of the effect of epinephrine nebulizer with subcutaneous injection in patients with acute asthma attack: a randomized clinical trial 2023-07-06 anticipated 66 Complete https://irct.ir/trial/70513 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Status asthma. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the end of the research and the agreement of the research team, a decision will be made to share non-identifiable data.
public Seyed Javad Seyedi
Akbar hospital, Kaveh-14 blvd.
Mashahd Iran (Islamic Republic of) 9177897157 +98 910 171 6090 mobinmdl94@gmail.com Mashhad University of Medical Sciences scientific Seyed Javad Seyedi
Akbar hospital, Kaveh-14 blvd.
Mashahd Iran (Islamic Republic of) 9177897157 +98 910 171 6090 mobinmdl94@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) 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. 2 years 14 years Both Children with asthma with conventional treatment response Children over 14 years old Children with asthma due to another side effect J45.902 Unspecified asthma with status asthmaticus Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. 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. 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. Mashhad University of Medical Sciences Approved 2021-04-24 Ethics Committee of Mashhad University of Medical Sciences Mashhad, Daneshgah Street, next to Hoizeh Cinema, Qorshi Building, Research and Technology Vice-Chancellor Mashahd Razavi Khorasan Iran (Islamic Republic of)