Comparison Of Only Ketamine Nebulization And Combined Ketamine Dexmedetomidine Nebulization Before Putting Paediatric Patients Under Anaesthesia for Surgeries As to Produce Sleep And to Relieve Anxiety

Completed

• Conditions: Paediatric Patients undergoing surgeries under General Anaesthesia

• Registration Number: CTRI/2017/03/008188
• Lead Sponsor: Armed forces Medical College Pune

Brief Summary

This is the double blinded randomized controlled Study to Compare efficacy  of nebulized ketamine (2mg/kg) and nebulized ketamine(1mg/kg)+dexmedetomidine(1mcg/kg)  combination as a premedication on sedation level  before the induction of Anaesthesia and facemask acceptance at the time of induction of anaesthesia in a paediatric patients undergoing surgeries under General Anaesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-03
• Last Update Posted: 2017-05-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Age more than 3 years and less than 10 years undergoing surgeries under General Anaesthesia.
• Paediatric patients with ASA physical status grade I or II 3.Tolerating Nebulization.

Exclusion Criteria

1.Known allergy/Hypersensitivity to study drug 2.Congenital diseases (Congenital Heart Diseases, Down’s syndrome etc.) 3.Child with developmental delay and/or with neurological disease (Cerebral palsy, Raised ICP etc ) 4.History of Chronic illness 5.known case of Bronchial Asthma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of nebulised ketamine and its combination with dexmedetomidine on sedation level in paediatric patients.	30 Minutes

Secondary Outcome Measures

Name	Time	Method
Occurrence of any adverse events in both the study groups.
To compare the effect of nebulised ketamine and its combination with dexmedetomidine on facemask acceptance during induction in operation room	30-45 Minutes

Trial Locations

Locations (1)

Armed forces Medical College Pune; 🇮🇳 Pune, MAHARASHTRA, India

Armed forces Medical College Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Shital Dharamkhele

Principal investigator

9545810604

dharamkhele@gmail.com