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A clinical trial to study the effects of two drugs, Ketamine and aminophylline for treatment of acute exacerbation of asthma in children.

Ketamine versus aminophylline for treating acute exacerbation of asthma in children: A randomized, controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/004000
Enrollment
48
Registered
2013-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute Exacerbation of Asthma in children

Interventions

Intervention1: Ketamine: Intravenous ketamine in dose of 0.5 mg/kg bolus over 20 minutes, followed by continuous infusion of 0.6 mg/kg/hour for 3 hours. Control Intervention1: Aminophylline: Intraveno

Sponsors

Govt Medical college hospital Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
change in PRAM(Pediatric respiratory assessment measure) scoreTimepoint: at 15, 30, 60, 120 and 180 minutes after intervention

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactVishal Guglani

Govt. medical college hospital, Chandigarh

dr.tiwariabhi@gmail.com9888893349

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026