Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery

NCT07410078 — Not applicable, Recruiting, 135 participants, Diskapi Yildirim Beyazit Education and Research Hospital

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A Comparative Evaluation of Oral Premedication Regimens in Pediatric Patients Undergoing Ambulatory Surgery

Registry	NCT07410078
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	135 (Estimated)
Sponsor	Diskapi Yildirim Beyazit Education and Research Hospital (Other gov)
Conditions	Pediatric Anesthesia, Premedication
Interventions	Oral Midazolam Premedication, Oral Midazolam plus Ibuprofen Premedication, Oral Midazolam plus Ketamine Premedication (Procedure)
Dates	start 2026-07-26, primary completion 2026-08-19 (estimated), completion 2026-09-01 (estimated), first posted 2026-02-13, last updated 2026-07-28
Locations	1 site in Turkey (Türkiye)

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Oral Midazolam Premedication	Active comparator	Procedure: Oral Midazolam Premedication	Participants in this arm will receive oral midazolam as premedication at a dose of 0.5 mg/kg (maximum 15 mg), administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation.
Oral Midazolam plus Ibuprofen Premedication	Active comparator	Procedure: Oral Midazolam plus Ibuprofen Premedication	Participants in this arm will receive a combination of oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) and oral ibuprofen at a dose of 10 mg/kg, administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation.
Oral Midazolam plus Ketamine Premedication	Active comparator	Procedure: Oral Midazolam plus Ketamine Premedication	Participants in this arm will receive oral midazolam at a dose of 0.5 mg/kg (maximum 15 mg) combined with oral ketamine at a dose of 3 mg/kg, administered approximately 20 minutes before transfer to the operating room. The medications will be administered once prior to anesthesia induction. Venipuncture tolerance, anxiety, and pain-related outcomes will be assessed during intravenous cannulation.

Oral Midazolam Premedication (Procedure): 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.
Oral Midazolam plus Ibuprofen Premedication (Procedure): 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.
Oral Midazolam plus Ketamine Premedication (Procedure): 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.

+Outcome measures

Primary outcomes

Proportion of Well-Tolerated Venipuncture [During intravenous cannulation in the operating room]: 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.

Secondary outcomes

Anxiety Scores [Assessed preoperatively before oral premedication and after premedication in the preoperative holding area.]: 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.
Pain Scores During Venipuncture [During intravenous cannulation in the operating room]: 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.

+Eligibility

Sex: All, ages: 4 Years to 12 Years

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

+Locations (1)

Facility	City	Country	Status
Ankara Etlik City Hospital	Ankara	Turkey (Türkiye)	Recruiting