CTRI/2025/12/099174
Not yet recruiting
Phase 3
A Randomised Control Trial comparing the Efficacy and Safety of Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine for Procedural Sedation in children aged 5-14 years.
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS)1 site in 1 country180 target enrollmentStarted: January 1, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS)
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Depth of Sedation
Overview
Brief Summary
The index Clincal trial "Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine in Children aged 5-14 years for Procedural Sedation" will be a Randomised Control Trial and is being registered in Clinical Trial Registry of India will be carried out in Department of Paediatrics PGIMS Rohtak with complete adherence to Clinical Trial protocols PI Dr. Kapil Bhalla , Co PI Dr. Bhaviya . The trial results will be avaliable in public domain and any clinical deviation if any, will be duly reported. Total duration of trial will be 9 months from the date of generation of ctri number
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged 5 -14 years having ASA physical status 1 and 2 as per ASA guidelines.
Exclusion Criteria
- •1-Any known allergy to drug 2- Children having Severe Liver or Renal Insufficiency 3- Severe bradycardia or atrioventricular block above II degree type 2 4- Children whose parents refuse to give consent.
Outcomes
Primary Outcomes
Depth of Sedation
Time Frame: 120 minutes or till clinical recovery.
Secondary Outcomes
- Time of recovery from sedation(30,45,60,75,90,105,120 minutes)
Investigators
Dr Kapil Bhalla
Department of Paediatrics
Study Sites (1)
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