To compare the effects of dexmedetomidine and ketamine in children undergoing procedure for congenital heart disease

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/04/052005
• Lead Sponsor: Vardhman Mahavir Medical College and Safdarjung Hospital

Brief Summary

This study is a prospective, interventional, comparative, randomized study to compare intranasal dexmedetomidine and intranasal ketamine as premedication  in pediatric patients with congenital heart disease undergoing cardiac surgical or interventional procedure under general anaesthesia with the hypothesis that intranasal dexmedetomidine is a better premedicant than intranasal ketamine in pediatric patients with congenital heart disease undergoing cardiac surgical or interventional procedure. Primarily, degree of sedation measured as sedation score will be recorded. Secondarily, parental separation score, intravenous cannula acceptance score, face mask acceptance score, hemodynamic variables, respiratory rate and oxygen saturation will be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-05
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Pediatric patients with congenital heart disease fulfilling the criteria of American Society of Anaesthesiologists Grade II and III, aged between 1-8 years posted for cardiac surgical or interventional procedure.

Exclusion Criteria

Patients with a known allergy to the study drugs, history of neurological or psychiatric illness, mental retardation, known nasal anomalies or rhinitis, baseline bradycardia and renal dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of premedication with intranasal dexmedetomidine and intranasal ketamine with respect to degree of sedation measured as sedation score in pediatric patients undergoing cardiac surgical or intereventional procedure.	The degree of sedation measured as sedation score at baseline,5,10,15,20,25,30 minutes after administration of the drug.

Secondary Outcome Measures

Name	Time	Method
1. To compare the efficacy of premedication with intranasal dexmedetomidine and intranasal ketamine with respect to:	A. Parental separation score

Trial Locations

Locations (1)

Vardhman Mahavir Medical College and Safdarjung Hospital; 🇮🇳 Delhi, DELHI, India

Vardhman Mahavir Medical College and Safdarjung Hospital

🇮🇳Delhi, DELHI, India

Palak Valecha

Principal investigator

9968937572

palakvalecha21@gmail.com