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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
Participants in this group will receive oral midazolam approximately 20 minutes before transfer to the operating room. The medication will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.
Participants in this group will receive oral midazolam and oral ibuprofen approximately 20 minutes before transfer to the operating room. Both medications will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.
Participants in this group will receive oral midazolam and oral ketamine approximately 20 minutes before transfer to the operating room. Both medications will be administered as a single dose prior to intravenous cannulation. Behavioral and pain-related assessments will be recorded during intravenous cannulation.
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
Proportion of Well-Tolerated Venipuncture
The proportion of children with well-tolerated venipuncture during intravenous cannulation, assessed using predefined behavioral and pain criteria recorded at the time of the venipuncture attempt.
Time frame: During intravenous cannulation in the operating room
Anxiety Scores
Anxiety levels assessed using the Children's Fear Scale (CFS) during intravenous cannulation.
Time frame: During intravenous cannulation in the operating room
Pain Scores During Venipuncture
Pain intensity assessed using the Wong-Baker Faces Pain Scale during intravenous cannulation.
Time frame: During intravenous cannulation in the operating room
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