A clinical trial to study the effects of two drugs, Ketamine and aminophylline for treatment of acute exacerbation of asthma in children.
Phase 4
- Conditions
- Health Condition 1: null- Acute Exacerbation of Asthma in children
- Registration Number
- CTRI/2013/09/004000
- Lead Sponsor
- Govt Medical college hospital Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
1) Children 1 to 12 years of age with acute moderate to severe exacerbation of asthma;
2) Pediatric Respiratory Assessment Measure(PRAM) score >= 5 at 2 hours of standard therapy.
Exclusion Criteria
1)Patients with history of prematurity, bronchopulmonary dysplasia, coexisting primary parenchymal pulmonary disease (e.g. cystic fibrosis) or coexisting congenital/acquired heart diseases.
2)Known hypertension
3)Known allergy to ketamine or aminophylline.
4) Raised intracranial pressure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in PRAM(Pediatric respiratory assessment measure) scoreTimepoint: at 15, 30, 60, 120 and 180 minutes after intervention
- Secondary Outcome Measures
Name Time Method adverse effects (vomiting, arrhythmias, hypotension, hypertension, dysphoric reactions, and oral secretions), change in pO2 and pCO2, change in PEFR, need for mechanical ventilation, and duration of hospital stay.Timepoint: at 15, 30, 60, 120 and 180 minutes after intervention except ABG which will be done at 0&180 mins