A Comparative Evaluation of Oral Premedication Regimens in Pediatric Patients Undergoing Ambulatory Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Proportion of Well-Tolerated Venipuncture
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Oral Midazolam plus Ibuprofen Premedication (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.
干预措施: Oral Midazolam plus Ketamine Premedication (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.
干预措施: Oral Midazolam Premedication (Procedure)
结局指标
主要结局
Proportion of Well-Tolerated Venipuncture
时间窗: 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.
次要结局
- Pain Scores During Venipuncture(During intravenous cannulation in the operating room)
- Anxiety Scores(Assessed preoperatively before oral premedication and after premedication in the preoperative holding area.)
研究者
Elif Sule Ozdemir
Principal İnvestigator
Ankara Etlik City Hospital