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Which Sedative Is Better for Children During Hearing Tests: nasal Dexmedetomidine or oral Midazolam.

Comparing Intranasal Dexmedetomidine and Oral Midazolam for Procedural Sedation in Pediatric Brainstem Evoked Response Audiometry: A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111239
Enrollment
92
Registered
2026-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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: Dexmedetomidine: 1 mcg/kg intranasal 1 hr before procedure. Control Intervention1: Midazolam: 0.5 mg/kg oral 1 hr before procedure.

Sponsors

Jalpaiguri Govt Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 1-6 years 2. ASA physical status I-II 3. Scheduled for BERA under sedation 4. Parental consent obtained

Exclusion criteria

Exclusion criteria: 1. Known allergy to study drugs 2. Pre-existing respiratory/cardiac issues 3. Developmental delay/uncooperative 4. Recent sedative/analgesic use 5. Contraindications to dexmedetomidine/midazolam

Design outcomes

Primary

MeasureTime frame
Successful sedation using Ramsay sedation scaleTimepoint: at 5 minutes interval after administration of the drug.—

Secondary

MeasureTime frame
Time to desired sedation onset Duration of sedation Parental satisfaction score Timepoint: Time to sedation onset- before procedure. Duration of sedation- during & after the procedure. Parental satisfaction score- after completion of procedure.—

Countries

India

Contacts

Public ContactDr Manisankar Nath

Jalpaiguri Govt Medical College

manisankarnath@gmail.com9434875617

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026