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Study aim
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Determining the effect of 5% saline nebulizer with Ventolin compared to 0.9% saline with Ventolin in the treatment of moderate asthma attack in children admitted to the emergency room and pediatric department
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 40 patients. Randomization will be by random number table, and patient checklist will be coded by letters A and B.
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Settings and conduct
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In this clinical trial, the effect of 5% saline nebulizer along with Ventolin will be compared with 0.9% saline along with Ventolin in the treatment of asthma attacks with moderate severity in children admitted to the emergency ward and the pediatric department of BuAli Hospital in Sari. Patients and treating physician will be blinded.
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Participants/Inclusion and exclusion criteria
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Children between 1 and 18 years old with a moderate asthma attack and a history of clinically confirmed asthma symptoms (wheezing, shortness of breath, and cough) will be included in the study, and will be excluded if they have heart disease, pneumonia, or rheumatic disease.
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Intervention groups
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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.
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.
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Main outcome variables
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Main outcome variables include improvement in dyspnea, retraction, SPO2 and consciousness, and normal heart rate and respiration rates.