Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorDiskapi Yildirim Beyazit Education and Research Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Pediatric patients aged 4-12 years

American Society of Anesthesiologists (ASA) physical status I-II

Scheduled for elective ambulatory (day-case) surgery

Eligible to receive oral premedication

Disqualifiers

ASA physical status III or higher

Moderate to severe intellectual disability

Moderate to severe autism spectrum disorder

Known allergy or contraindication to midazolam, ketamine, or ibuprofen

Trial design

Treatments tested in this trial

  • Oral Midazolam Premedication
  • Oral Midazolam plus Ibuprofen Premedication
  • Oral Midazolam plus Ketamine Premedication

Treatment groups

135 Participants
are divided into 3 treatment groups

Sponsors and collaborators