FULL DETAILS (Read-only)

CTRI Number  CTRI/2013/09/004000 [Registered on: 18/09/2013] Trial Registered Retrospectively
Last Modified On: 18/09/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, Ketamine and aminophylline for treatment of acute exacerbation of asthma in children. 
Scientific Title of Study   Ketamine versus aminophylline for treating acute exacerbation of asthma in children: A randomized, controlled trial  
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishal Guglani 
Address  Department of Paediatrics, Govt. medical college hospital, Chandigarh-160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121519  
Fax    
Email  vishal_guglani@yahoo.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Abhimanyu Tiwari 
Address  Department of Paediatrics, Govt. medical college hospital, Chandigarh-160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9888893349  
Fax    
Email  dr.tiwariabhi@gmail.com  
 
Details Contact Person
Public Query
 
Name  Vishal Guglani 
Address  Department of Paediatrics, Govt. medical college hospital, Chandigarh-160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121519  
Fax    
Email  vishal_guglani@yahoo.com  
 
Source of Monetary or Material Support  
material support from deptt. of paediatrics  
 
Primary Sponsor
Modification(s)  
Name  Govt Medical college hospital Chandigarh 
Address  Deptt of paediatrics 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Vishal Guglani  Department of Pediatrics  Govt. medical college hospital, Chandigarh
Chandigarh
 
9646121519

vishal_guglani@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Govt. Medical College Hospital, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Acute Exacerbation of Asthma in children 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aminophylline  Intravenous aminophylline 5 mg/kg bolus over 20 minutes followed by continuous infusion of 0.9 mg/kg/hour for 3 hours. 
Intervention  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.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
change in PRAM(Pediatric respiratory assessment measure) score  at 15, 30, 60, 120 and 180 minutes after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
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.   at 15, 30, 60, 120 and 180 minutes after intervention except ABG which will be done at 0&180 mins 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   28/01/2012 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Brief Summary  

This is an open-label randomized controlled trial comparing 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, with intravenous aminophylline 5 mg/kg bolus over 20 minutes followed by continuous infusion of 0.9 mg/kg/hour for 3 hours in children 1 to 12 years of age with acute moderate to severe exacerbation of asthma. The study will be conducted at department of Pediatrics of Govt. Medical College Hospital, Chandigarh, India. Primary outcome measure will be change in Pediatric Respiratory Assessment Measure (PRAM) score. Secondary outcome measures will include 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.  

 

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