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IRCT20230930059568N1 IRCT 2023-12-26 Mazandaran University of Medical Sciences Comparison of the effect of saline nebulizer 5% with Ventolin VS saline nebulizer 0.9% in the management of moderate asthma attack Comparison of the effect of saline nebulizer 5% with Ventolin VS saline nebulizer 0.9% in the management of moderate asthma attack 2023-11-22 anticipated 40 Complete https://irct.ir/trial/72953 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 40 patients with moderate asthma who meet the study’s inclusion criteria are selected. First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 40 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 20 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 40, Blinding description: Patients and physicians will be blinded so that none of them will know which group they are in. 3 Moderate Asthma. Intervention 1: Intervention group: In the intervention group, a vial of salbutamol (Ventolin, salbutamol sulfate 0.15 mg per kg with a minimum dose of 2.5 mg) in 2.5 mL of 5% hypertonic saline (minimum volume of 5 cc) is prescribed for 20 minutes to 3 doses. Intervention 2: Control group: For the control group, a vial of salbutamol (Ventolin, salbutamol sulfate 0.15 mg per kg with a minimum dose of 2.5 mg) in 2.5 mL of 0.9% normal saline (minimum volume of 5 cc) is prescribed for 20 minutes up to 3 doses. Yes - There is a plan to make this available What will be shared: Part of the data is accessible When: Starting in March 2025 To whom: Everyone Conditions: Systematic review articles Where to obtain: Contact Dr. Abbas Dabbaghzadeh: dabbaghzadeh@mazums.ac.ir How to obtain: After contact, information is sent within a few days Comments:
public Dr. Abbas Dabbaghzadeh
Pediatric Infectious Diseases Research Center, Buali hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 dabbaghzadeh@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Abbas Dabbaghzadeh
Pediatric Infectious Diseases Research Center, Buali hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 dabbaghzadeh@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age 1-18 years Moderate asthma attack Having a history of asthma symptoms (wheezing, shortness of breath and cough) that has been clinically confirmed 1 year 18 years Both Heart disease Pneumonia Rheumatic disease J45.40 Moderate persistent asthma, uncomplicated Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, a vial of salbutamol (Ventolin, salbutamol sulfate 0.15 mg per kg with a minimum dose of 2.5 mg) in 2.5 mL of 5% hypertonic saline (minimum volume of 5 cc) is prescribed for 20 minutes to 3 doses. Control group: For the control group, a vial of salbutamol (Ventolin, salbutamol sulfate 0.15 mg per kg with a minimum dose of 2.5 mg) in 2.5 mL of 0.9% normal saline (minimum volume of 5 cc) is prescribed for 20 minutes up to 3 doses. Improvement of Dyspnea. Timepoint: 0, 20, 40 and 60 minutes following treatment. Method of measurement: Observation. Retraction. Timepoint: 0, 20, 40 and 60 minutes following treatment. Method of measurement: Observation. SPO2. Timepoint: 0, 20, 40 and 60 minutes following treatment. Method of measurement: Pals oxymeter. Heart rate. Timepoint: 0, 20, 40 and 60 minutes following treatment. Method of measurement: Measuring Heart rate. Respiratory rate. Timepoint: 0, 20, 40 and 60 minutes following treatment. Method of measurement: Measuring respiratory rate. Mazandaran University of Medical Sciences Approved 2023-09-23 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for Research, Moallem square, Sari Sari Mazandaran Iran (Islamic Republic of)