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Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 14, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor 2 versions Re-verified since May 7, 2026, no change to tracked fieldsv3-v4
  2. Notable Recruitment opened
    • Start date changed from estimate of May 1, 2026 to May 5, 2026
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study aims to compare the effects of intranasal dexmedetomidine and oral midazolam as premedication in pediatric patients undergoing elective inguinal and urological surgery under general anesthesia. Premedication plays a critical role in reducing preoperative anxiety, facilitating parent-child separation, and improving cooperation during anesthesia induction in pediatric patients. While oral midazolam is widely used, it has several limitations, including variable bioavailability and the risk of paradoxical reactions. Intranasal dexmedetomidine has emerged as a promising alternative due to its sedative, anxiolytic, and minimal respiratory depressant effects. In this prospective, randomized, double-blind, controlled study, patients aged 2-10 years will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. The primary outcome is the proportion of patients achieving adequate sedation at induction, defined as a Ramsay Sedation Score (RSS) ≥2. Secondary outcomes include perioperative hemodynamic stability, parent-child separation anxiety, mask acceptance during induction, postoperative emergence agitation, recovery time, and the need for rescue sedation.
Trial Details
NCT Number NCT07565116
Lead Sponsor Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Conditions
(from sponsor)
Pediatric Anesthesia, Preoperative Anxiety, Emergence Agitation
Related terms Emergence Delirium
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov