Comparing Oral and Nasal Midazolam for Sedation in Children as a premedication

A Comparative Study of Effectiveness of Oral Midazolam versus Intranasal Midazolam as Sedative Premedication in Pediatric Surgeries- A Prospective Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/01/100159

Enrollment

Registered

2026-01-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Control Intervention1: Intranasal Midazolam as Sedative Premedication in Pediatric Surgeries: Intranasal Midazolam as Sedative Premedication in Pediatric Surgeries Control Intervention2: midazolam as

Eligibility

Inclusion criteria

Inclusion criteria: Scheduled for Elective Surgeries under GA ASA 1,2 Obtained Written Informed Consent from Patient or Legal Guardian

Exclusion criteria

Exclusion criteria: History of Allergy or Hypersensitivity to Benzodiazepines Childern with LRI or Nasal Pathology Neurological disorders or Developmental Delay Use of Sedatives within 48 hours prior to Surgery

Design outcomes

Primary

Measure	Time frame
To compare the sedation effectiveness of Intranasal versus Oral Midazolam in Pediatric Patients undergoing Elective SurgeryTimepoint: From 0 mins of administering midazolam till parentral separation	—

Secondary

Measure	Time frame
To compare the onset of time and peak effect of sedation.To access anxiety levels at Parenteral separation.To evaluate mask acceptance score.To evaluate patients acceptability and adverse effectsTimepoint: From 0 mins of Parentral Separation till Good Mask Acceptance	—

Countries

India

Contacts

Public ContactDr V K Shobana

Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem

shanushanmugasundharam@gmail.com8056603011

Outcome results

None listed

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