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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

Prospective randomized atudy to compare two does of dexmedetomidine in combination with standard dose ketamine delivered as atomised intranasal spray in paediatric population for evaluating parental separation without cryand ease of intravenous cannulation. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065505
Enrollment
70
Registered
2024-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Mucosal atomiser spray: Dexmedetomidine and ketamine combination is administered intranasally 45 minutes before procedure. 0.5ml is administered in each nostril Control Intervention1:

Sponsors

Saveetha medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA status 1and 2

Exclusion criteria

Exclusion criteria: Children less than 1 year and more than 10years Organ dysfunction Congenital heart disease Cardiac arrhythmia Mental retardation

Design outcomes

Primary

MeasureTime frame
Time of successful separation from mother using sedation score at 5minutes interval after premedication, Ease of intravenous cannulation using FLACC scale Timepoint: 0 minutes , 5 minutes , 10 minutes, 15 minutes ,20 minutes and 30 minutes

Secondary

MeasureTime frame
Adverse effects, Wakeup behaviourTimepoint: After extubation

Countries

India

Contacts

Public ContactMahalakshmi R

Saveetha medical college and hospital

dr_yach@yahoo.co.in9790963362

Outcome results

None listed

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