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Study aim
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Determining the effect of Pulmicort on the Cough rate ;
Determining the effect of Pulmicort on the rate of wheezing;
Determining the effect of Pulmicort on the duration of hospitalization;
Determining the effect of Pulmicort on the Workup breathing;
Determining the effect of Pulmicort on the side effects (palpitations, tremors) of children with acute asthma attacks.
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Design
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A clinical trial with the control group, phase 3, ِDouble blinded, parallel-group design of 80 patients, randomized groups ( Block form ), the size of two control and intervention groups are equal
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Settings and conduct
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This study is a randomized clinical trial study. The place of work is Ali Asghar Children's Hospital.
At the beginning of the study, all children with asthma attacks will be tested for asthma scores. They are then randomly (Block form) divided into two groups of tests and controls (an equal number in each group). All patients are treated with standard asthma treatment, including oxygen and beta-2 agonists and systemic corticosteroids, the first group receives inhale budesonide (Pulmicort), the second group receives normal saline (placebo). The follow-up of the patient will be 6, 12, 24, and 48 hours later.
How to blind: Sealed envelope, doctor, and patient are blinded and the nurse is the triage or ward knows the information.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
2 to 12 years;
acute asthma attack;
No other diseases;
exclusion criteria:
cardiology disease;
taking steroid medications for the past 7 days.
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Intervention groups
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Control and Intervention groups: Children with acute asthma attacks
Both groups received basic asthma treatment.
The intervention group received budesonide nebulization and the control group received normal saline nebulization.
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Main outcome variables
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Cough rate; Weezing score; Workup Breathing; duration of hospitalization; possible complications