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
Sponsors and collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Lead sponsor
Ankara Etlik City Hospital
Sponsor institution