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

Comparison of intranasal dexmedetomidine and intranasal ketamine as premedication in pediatric patients undergoing cardiac surgical or interventional procedure for congenital heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/052005
Enrollment
60
Registered
2023-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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: Intranasal dexmedetomidine as premedication: Pediatric patients posted for cardiac surgical or interventional procedure for congenital heart disease will be given intranasal dexmedetomi

Sponsors

Vardhman Mahavir Medical College and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: The degree of sedation measured as sedation score at baseline,5,10,15,20,25,30 minutes after administration of the drug.—

Secondary

MeasureTime frame
1. To compare the efficacy of premedication with intranasal dexmedetomidine and intranasal ketamine with respect to: A. Parental separation score B. Intravenous cannula acceptance score C. Face mask acceptance score 2. To compare the effect of premedication with intranasal dexmedetomidine and intranasal ketamine on hemodynamic variables, respiratory rate and oxygen saturation. Timepoint: 1. The following parameters will be measured at baseline,5,10,15,20,25,30 minutes after administration of the drug : A. Parental separation score B. Intravenous cannula acceptance score C. Face mask acceptance score 2. Hemodynamic variables, respiratory rate and oxygen saturation measured at baseline,5,10,15,20,25,30 minutes after administration of the drug—

Countries

India

Contacts

Public ContactAmita Gupta

Vardhman Mahavir Medical College and Safdarjung Hospital

amitaguptadr@gmail.com9910382190

Outcome results

None listed

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