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Comparison of Dexmedetomidine and Dexmedetomidine-Ketamine combination efficacy as intranasal premedication in paediatric infraumbilical surgeries

Not yet recruiting
Conditions
Medical and Surgical,
Registration Number
CTRI/2025/03/081696
Lead Sponsor
Dr Fehima Haris
Brief Summary

This is a comparative observation study comparing effectiveness of intranasal dexmedetomidine 3mcg/kg with intranasal dexmedetomidine(2mcg/kg)-ketamine(2mg/kg) combination as a premedication in paediatric infraumbilical surgeries . While there has been much research on the individual effectiveness of dexmedetomidine and ketamine as paediatric premedication,  there has been limited evidence on their combined efficacy . Our primary objective is to compare effectiveness of intranasal dexmedetomidine versus dexmedetomidine-ketamine combination as a premedication in terms of mask acceptance score in paediatric patients undergoing general anaesthesia for infraumbilical surgeries.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
144
Inclusion Criteria

Paediatric patients of age 1-6 years of either sex undergoing elective infraumbilical surgeries of ASA physical status I or II.

Exclusion Criteria

Known allergy to study drugs Cardiac arrhythmia or congenital heart disease Raised intracranial tension Children with mental retardation Intranasal mass or nasal bleeding.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare the effectiveness of intranasal dexmedetomidine versus intranasal dexmedetomidine-ketamine combination as a premedication in terms of mask acceptance score in paediatric patients undergoing general anaesthesia for infraumbilical surgeriesMask acceptance score will be assessed at the time of induction that is 30 minutes after giving premedication
Secondary Outcome Measures
NameTimeMethod
To assess level of sedation using Ramsay sedation scoreTo determine Child-parent separation score

Trial Locations

Locations (1)

Government medical college Kozhikode

🇮🇳

Kozhikode, KERALA, India

Government medical college Kozhikode
🇮🇳Kozhikode, KERALA, India
Dr Fehima Haris
Principal investigator
9539833177
fehimaharis04282@gmail.com

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