Comparative Assessment of Oral Premedication Regimens in Pediatric Ambulatory Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Oral Midazolam Premedication
  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.
• Процедура Oral Midazolam plus Ibuprofen Premedication
  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.
• Процедура Oral Midazolam plus Ketamine Premedication
  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.

Первичные конечные точки

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

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT07410078 · AEŞH-EK-2025-320

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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