The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in the emergency room.
Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids. Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in the emergency room has any benefit on, symptom score, hospitalization rate and time to discharge from emergency room. Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the emergency room for acute wheezing. Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline. Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times
Children will receive 2 ml of saline every 20 minutes for 3 times
Kecioren Education and Training Hospital
Ankara, Kecioren, Turkey (Türkiye)
Pulmonary index score at 2 to 4 hours
Time frame: 2 to 4 hours
Hospital admission rates
Time frame: 4 hours
Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.
Time frame: 4 hours
Respiratory rate
Time frame: 2 hours
Oxygen saturation
Time frame: 2 hours
Time to discharge from the Emergency Department to home
Time frame: 2 to 4 hours
Adverse reactions.
Time frame: 2-5 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.