A Randomized Clinical Trial Comparing Ketamine and Fentanyl for Postoperative Pain Management and Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
This study is designed to compare the effectiveness of two medications, ketamine and fentanyl, in managing pain and preventing delirium in children aged 3 to 8 years who are undergoing tonsillectomy and adenoidectomy surgery. The study aims to determine which medication is better at reducing pain and preventing delirium after surgery, and which one results in faster recovery times and fewer side effects. Children participating in the study will be randomly assigned to receive either ketamine or fentanyl during their surgery. The study will measure pain levels, recovery times, and any side effects experienced by the children. The results of this study will help doctors and anesthesiologists make better decisions about which medication to use for pain management in children undergoing tonsillectomy and adenoidectomy.
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
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 8 years
- •Scheduled for tonsillectomy and adenoidectomy
- •American Society of Anesthesiologists (ASA) Physical Status I-III
排除标准
- •American Society of Anesthesiologists' Physical Status ≥4
- •Known hypersensitivity or allergy to any of the study medications (acetaminophen, ketamine, fentanyl)
- •Receiving chronic opioid analgesic therapy prior to surgery
- •Renal disease
- •Hepatic disease
- •Obesity (body mass index greater than 99th percentile for age)
研究组 & 干预措施
Group I (Ketamine group)
The patients in this group will have intravenous ketamine (0.5 mg/kg) during induction
干预措施: ketamine (Drug)
Group II (Fentanyl Group)
The patients in this group will have intravenous fentanyl (1 µg/kg) during induction
干预措施: fentanyl (Drug)
结局指标
主要结局
Pain Scores
时间窗: From the enrollment to 8 hours post-surgery
Face, Legs, Activity, Cry, Consolability (FLACC) Scale Range: 0 to 10 Higher scores indicate worse pain 0 = no pain, 10 = worst possible pain (Assessment of Behavioural Score: ; 0 = Relaxed and comfortable ; 1-3 = Mild discomfort ; 4-6 = Moderate pain ; 7-10 = Severe discomfort/pain.)
次要结局
- Incidence of Emergence Delirium Following Pediatric Tonsillectomy and Adenoidectomy(From the enrollment to 8 hours post-surgery)
研究者
Yunus Oktay Atalay
MD, Prof, DESAIC
Medipol University