Comparative efficacy of nebulised salbutamol, salbutamol plus budesonide and salbutamol plus fluticasone in the management of acute exacerbation of bronchial asthma in children: a study protocol of a randomized controlled trial

Background: Acute exacerbation of asthma in children is one of the most common emergencies in children. Use of inhaled corticosteroids (ICS) in combination with bronchodilator as initial therapy has shown to be beneficial when compared to oral corticosteroids. ICS commonly used in acute exacerbation in children are budesonide and fluticasone. Pediatric respiratory assessment measure (PRAM) Score is widely used standardized score in clinical and as well in research studies for 2-17years children. It has five parameters with total scores from 0-10 where higher scores indicate sicker patient. Methods: This study is planned to study efficacy of nebulised salbutamol vs salbutamol plus budesonide vs salbutamol plus fluticasone in management of acute exacerbation of asthma in children. After written informed consent, participants will be enrolled by computerized block randomization list to three groups. Each group will be administered the medication as per their allocation and weight band. Vitals and PRAM score will be recorded 0, 2 and 4 hours from the start of treatment. PEFR will be recorded with help of peak flowmeter at 2 hours and 4 hours from initiation of treatment. At the end of 4 hours, patient outcome will be noted. After 3 months, child will be followed to know level of control of symptoms as per GINA guidelines. Concealment will be disclosed after statistical analysis performed and results are locked. Conclusions: If this intervention study shows evidence of a significant difference between three arms of treatment, then it may guide first line of treatment of acute exacerbation of paediatric asthma. Trial Registration: CTRI/2023/07/054624 registered prospectively.