Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Oral Midazolam Premedication
Procedure/SurgeryParticipants 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.
Oral Midazolam plus Ibuprofen Premedication
Procedure/SurgeryParticipants 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.
Oral Midazolam plus Ketamine Premedication
Procedure/SurgeryParticipants 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.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: Oral Midazolam PremedicationActive comparator 1 intervention
Group B: Oral Midazolam plus Ibuprofen PremedicationActive comparator 1 intervention
Group C: Oral Midazolam plus Ketamine PremedicationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Well-Tolerated Venipuncture
The proportion of children with well-tolerated venipuncture during intravenous cannulation, assessed using the Children's Fear Scale (CFS), a validated 5-point scale ranging from 0 to 4 (0 = no fear; 4 = extreme fear). Well-tolerated venipuncture is defined as a CFS score \< 3 at the time of the venipuncture attempt.
Time frame
During intravenous cannulation in the operating roomSecondary outcomes
1
Anxiety Scores
The mYPAS is an observational behavioral scale consisting of five domains (activity, vocalization, emotional expressivity, state of arousal, and use of parents). Scores are calculated using the original weighted scoring algorithm and generate a standardized total score ranging from 23.3 to 100, with higher scores indicating greater anxiety. Clinically significant anxiety is defined as mYPAS ≥ 30.
Time frame
Assessed preoperatively before oral premedication and after premedication in the preoperative holding area.2
Pain Scores During Venipuncture
Pain intensity assessed using the Wong-Baker Faces Pain Rating Scale, a validated 6-face scale scored from 0 to 10: 0 = no pain 10 = worst pain imaginable Higher scores indicate greater pain intensity.
Time frame
During intravenous cannulation in the operating roomSponsors and contacts
Click on the lead sponsor to view all of their trials.
Diskapi Yildirim Beyazit Education and Research Hospital
Lead sponsor
Ankara Etlik City Hospital
Sponsor institution
Source ClinicalTrials.gov