A clinical trial to study the effect of addition of Budesonide nebulisation to standard first line therapy in management of acute asthma exacerbations.
- Conditions
- Health Condition 1: J459- Other and unspecified asthma
- Registration Number
- CTRI/2024/07/070571
- Lead Sponsor
- Government Medical College and Hospital Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Children 2 to 18 years of age diagnosed to have an acute exacerbation of asthma. The diagnosis will be based on the following criteria:
1.Children aged 2 to 18 years of age presenting to paediatric emergency with acute exacerbation of asthma having Paediatric asthma severity score of 8 to 15
And
2. Is a known case of childhood asthma or past history of at least two similar episodes in last 12 months relieved with bronchodilator therapy or already on controller therapy or with family history of asthma ,atopy ,nebulisations or personal history of atopic dermatitis, food allergy or allergic rhinitis.
1. Presence of signs or symptoms suggestive of pneumonia, tuberculosis, heart disease croup, pertussis, measles, foreign body aspiration.
2.Documented fever >38 degrees Celsius
3.Life threatening exacerbation attack necessitating PICU admission and/or intubation owing to respiratory failure or depressed consciousness (GCS <8), and/or inotropes
4.Children enrolled in any other trial.
5.Children previously enrolled in this trial within last one month
6.Children who have received systemic corticosteroids for any indication within the previous 4weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in proportion of patients who needed systemic corticosteroid at one hour of presentation in each group <br/ ><br>Timepoint: One hour of presentation
- Secondary Outcome Measures
Name Time Method Difference in mean duration of hospital stay in each group <br/ ><br>Timepoint: At discharge;Difference in mean reduction in Pediatric asthma severity score indicating clinical improvement at one hour of presentation <br/ ><br>Timepoint: One hour of presentation