Intranasal Dexmedetomidine vs Intranasal Dexmedetomidine with midazolam for reducing separation anxiety in children undergoing elective surgeries.

A Double Blinded Randomised controlled trial: Comparing the effectiveness of Intranasal Dexmedetomidine and Midazolam combination with Intranasal Dexmedetomidine alone as a premedication in pediatric elective surgeries - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086099

Enrollment

120

Registered

2025-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

None listed

Interventions

Intervention1: Premedication - Intranasal dexmedetomidine (1mcg/kg)and midazolam (0.2mg/kg) combination: single dose, given intranasally 45 minutes before induction of anesthesia Control Interventio

Eligibility

Inclusion criteria

Inclusion criteria: Consenting parents/legal guardians, ASA 1 & 2 patients, Age 1 to 8 years, Elective surgical procedure

Exclusion criteria

Exclusion criteria: Non- consenting patients/ legal guardians, Upper respiratory tract infection, Difficult airway Hypersensitivity to dexmedetomidine/ midazolam History of mental retardation/ psychiatric illness, Congenital heart diseases, cardiac arrhythmias.

Design outcomes

Primary

Measure	Time frame
Assess the successful parent- child separation between two paediatric groups: Intranasal dexmedetomidine and midazolam combination with intranasal dexmedetomidine alone.Timepoint: Just before shifting the child to the operating room( i.e, @ 45 minutes post- administration of premedication)	—

Secondary

Measure	Time frame
Mask acceptability & time to achieve satisfactory/good sedation level.Timepoint: Mask Acceptibility seen at time of Anesthesia induction( at 45 minutes post administration of study premedication drug). Sedation levels seen at - At baseline, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes & 45 minutes of post administration of study premedication drug till anesthesia induction	—

Measure

Time frame

Mask acceptability & time to achieve satisfactory/good sedation level.Timepoint: Mask Acceptibility seen at time of Anesthesia induction( at 45 minutes post administration of study premedication drug). Sedation levels seen at - At baseline, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes & 45 minutes of post administration of study premedication drug till anesthesia induction

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Countries

India

Contacts

Public ContactSneha K

Medanta The Medicity

dinesh2501@yahoo.com.

Outcome results