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To study the effectiveness of intranasal atomized dexmedetomidine versus ketamine as a premedication for providing sedation and anxiolysis in children undergoing adenotonsillectomy in general anaesthesia.

A randomized comparative study of intranasal atomized dexmedetomidine versus ketamine as a premedication in children undergoing adenotonsillectomy in general anaesthesia at SMS Medical College Jaipur - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095383
Enrollment
100
Registered
2025-09-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: J353- Hypertrophy of tonsils with hypertrophy of adenoids

Interventions

Intervention1: Intranasal atomized dexmedetomidine (2.5 mcg per kg): Patients will be administered intranasal atomized dexmedetomidine (2.5 mcg per kg diluted to 2.6 mL with 0.9 percent saline) using

Sponsors

Department of Anaesthesia Sawai Man Singh Medical College Jaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children scheduled for adenotonsillectomy under general anaesthesia. 2.Patients belonging to American Society of Anaesthesiologists (ASA) class I and II. 3.Patient s parents willing to give informed written consent.

Exclusion criteria

Exclusion criteria: 1.Patients with known allergies to dexmedetomidine or ketamine. 2.Patients with weight greater than 25 kg. 3.Patients with any congenital anomaly or syndrome. 4.Patients with history of seizures. 5.Patients with upper respiratory tract infection. 6.Patients with airway malformations or anticipated difficult airway. 7.Patients with intellectual disability. 8.Patients involved in any other study.

Design outcomes

Primary

MeasureTime frame
1.To assess and compare the degree of sedation using the University of Michigan Sedation Scale (UMSS) between intranasal atomized dexmedetomidine versus ketamine. 2.To assess and compare the ease of parental separation using Parental Separation Anxiety Score (PSAS) between the two groups Timepoint: 10 minutes, 20 minutes, 30 minutes—

Secondary

MeasureTime frame
1.To assess and compare mask acceptance using Mask Acceptance Score (MAS) between the two groups . 2.To assess and compare the ease of venous cannulation using Groningen Distress Rating Scale (GDRS) between the two groups. 3.To assess and compare vital parameters like Heart Rate, blood pressure, oxygen saturation between the two groups. 4.To assess and compare adverse effects if any, between the two groups. 5.To assess and compare the incidence of emergence agitation using WATCHA Scale between the two groups. Timepoint: 10 minutes, 20 minutes, 30 minutes—

Countries

India

Contacts

Public ContactDr Mahak Goyal

Sawai Man Singh Medical College Jaipur

drmamtasharma@hotmail.com9829566077

Outcome results

None listed

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