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A study comparing the use of two medicines Dexmedetomidine and Midazolam used intranasally and its effect on calming down children before planned surgeries.

Comparison of Intranasal Dexmedetomidine with Intranasal Midazolam as Premedication in Children Undergoing Elective Surgeries- A Randomised Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/096896
Enrollment
100
Registered
2025-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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: Group D recieves Intranasal Dexmedetomidine 1mcg/kg 30 minutes prior to surgery Intervention2: Intranasal Midazolam: Group M recieves Intranasal Midazolam 0.

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 1 to 8 years 2. ASA I and II 3. Elective surgeries

Exclusion criteria

Exclusion criteria: 1. Patients with respiratory tract infections or nasal obstruction. 2. Congenital anomalies to nasal or oral cavity 3. H/O allergy 4. Parental refusal to consent

Design outcomes

Primary

MeasureTime frame
To compare the preoperative sedation and response of child to parental separation, in patients receiving intranasal dexmedetomidine and intranasal midazolam as premedication.Timepoint: 0,5,10,15,20,25,30 MINUTES—

Secondary

MeasureTime frame
Preoperative sedation scoreTimepoint: 0,5,10,15,20,25,30 MINUTES;Mask acceptanceTimepoint: After 30 MINUTES;Post operative agitationTimepoint: After surgery—

Countries

India

Contacts

Public ContactAnjana B S

Malankara Orthodox Syrian Church Medical College

rakheeksd79@gmail.com94955 67033

Outcome results

None listed

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