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
|
|
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)
|
|
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. |