IV versus Nebulized Dexmedetomidine for Preoperative Sedation in Pediatric Adenotonsillectomy: A Dose-Titration Randomized Controlled Trial

Intravenous versus Nebulized Dexmedetomidine for Preoperative Sedation in Pediatric Adenotonsillectomy: A Dose-Titration Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202511627656950

Enrollment

Registered

2025-11-26

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Ear, Nose and Throat Mental and Behavioural Disorders Anaesthesia

Interventions

IV dexmedetomidine

Nebulized dexmedetomidine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 46 Children (ASA I–II), aged 2–6 years, scheduled for elective adenotonsillectomy, after Parental consent

Exclusion criteria

Exclusion criteria: Allergy to dexmedetomidine, respiratory illness, cardiac disease, bradycardia, developmental delay, or airway anomalies.

Design outcomes

Primary

Measure	Time frame
The cumulative intravenous and nebulized dexmedetomidine doses required to reach target sedation (UMSS =2)	—

Secondary

Measure	Time frame
Parent Separation Anxiety Scale (PSAS);Mask Acceptance Score (MAS);Hemodynamic parameters (HR, BP, SpO2);• Adverse events (bradycardia, hypotension, desaturation) • Parental satisfaction (0–10 scale) • Recovery profile: Pain scores, emergence delirium (Watcha Scale), and recovery time (UMSS 0)	—

Countries

Egypt

Contacts

Public ContactAml Salama

Professor of Family medicine

aml_salama2002@yahoo.com+201008131074

Outcome results

None listed

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