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Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 28, 2026 (before its estimated August 19, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Recruitment opened
    • Start date changed from estimate of Feb 19, 2026 to Jul 26, 2026
    • Site details revised
    v3
  2. Secondary endpoints: details revised at 2 of 2 entriesv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 prospective, three-arm study aims to evaluate the effects of different oral premedication regimens on venipuncture tolerance in pediatric patients undergoing ambulatory surgery. Children aged 4-12 years scheduled for elective day-case procedures will receive oral midazolam alone, midazolam combined with ibuprofen, or midazolam combined with ketamine prior to anesthesia induction. The primary outcome is the proportion of children with well-tolerated venipuncture, assessed using standardized behavioral and pain scales. Secondary outcomes include anxiety levels, venipuncture success parameters, time to successful intravenous access, and parent and anesthesiologist satisfaction. In cases of inadequate premedication or failed venipuncture, a predefined rescue inhalational induction protocol will be applied to ensure patient safety. The study aims to identify clinically effective premedication strategies that may improve cooperation and reduce distress during intravenous cannulation in pediatric ambulatory anesthesia.
Trial Details
NCT Number NCT07410078
Lead Sponsor Diskapi Yildirim Beyazit Education and Research Hospital
Conditions
(from sponsor)		 Pediatric Anesthesia, Premedication
Related terms Anxiety Disorders
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov