study which compares two doses of dexmeditomedine drug in combination with fixed dose of ketamine drug delivered as intranasal spray in children for evaluating parental seperation without cry and ease of intravenous cannulation
Phase 4
Not yet recruiting
- Conditions
- Medical and Surgical,Healthy Asa1 and Asa2 volunteers
- Registration Number
- CTRI/2024/04/065505
- Lead Sponsor
- Saveetha medical college and hospital
- Brief Summary
To compare the efficacy of two different doses of dexmedetomidine with fixed dose of ketamine given as a intranasal atomised spray for paediatric premedication and assessment of duration taken from administration of drug to calm separation of child from mother, assessment of ease of intravenous cannulation, wake up behaviour and adverse effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
ASA status 1and 2.
Exclusion Criteria
Children less than 1 year and more than 10years Organ dysfunction Congenital heart disease Cardiac arrhythmia Mental retardation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time of successful separation from mother using sedation score at 5minutes interval after premedication, 0 minutes , 5 minutes , 10 minutes, 15 minutes ,20 minutes and 30 minutes Ease of intravenous cannulation using FLACC scale 0 minutes , 5 minutes , 10 minutes, 15 minutes ,20 minutes and 30 minutes
- Secondary Outcome Measures
Name Time Method Adverse effects, Wakeup behaviour
Trial Locations
- Locations (1)
Saveetha medical college and hospital
🇮🇳Chennai, TAMIL NADU, India
Saveetha medical college and hospital🇮🇳Chennai, TAMIL NADU, IndiaMahalakshmiPrincipal investigator9943245009drmahalakshmi.rs@gmail.com