Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery
Recruiting · NCT07410078 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Cognitive ability sufficient to complete behavioral and pain scale assessments
- Written informed consent obtained from a parent or legal guardian
Exclusion criteria
- 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
- History of sedative or opioid use within the previous 24 hours
- Complete loss of premedication due to vomiting
Where it is running
1 location listed.
- Ankara Etlik City Hospital - Ankara, Turkey (Türkiye)