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A Study Comparing Two Sedative Drugs in Children Undergoing Anaesthesia

Comparative Analysis of Intranasal Midazolam versus Dexmedetomidine as Paediatric Premedication: Impact on Sedation, Anxiolysis, Mask Acceptance, Procedure Response, Hemodynamic Stability, and Postoperative Agitation - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106083
Enrollment
80
Registered
2026-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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: Group M: Midazolam intranasal spray: 0.2 mg/kg of intranasal midazolam once 30 minutes before shifting inside the operating room/giving general anaesthesia Control Intervention1: Group

Sponsors

Alok Belgaumkar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 4 to 10 years 2. ASA Class I & II patients 3. Undergoing elective surgeries under general anaesthesia 4. Willingness of parent/guardian to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Parent refusal for consent 2. Known allergy or contraindication to midazolam or dexmedetomidine 3. Patients with upper respiratory tract infection or nasal pathology 4. Children with cardiovascular, renal, hepatic, or neurological disorders 5. History of delayed development or psychological disorders 6. Children on sedative or antiepileptic medications 7. Emergency surgeries

Design outcomes

Primary

MeasureTime frame
There is no significant difference between intranasal midazolam and intranasal dexmedetomidine in terms of sedation quality, anxiolysis, and perioperative cooperation in paediatric patients.Timepoint: Baseline (before intranasal drug), 15 minutes and 30 minutes after intranasal premedication in preoperative holding area.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactAlok Belgaumkar

Sri Sidhartha Medical College

alokbelgaumkar@gmail.com8762771374

Outcome results

None listed

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