Comparing the Quality of Recovery after Melatonin, Midazolam, or Play Therapy in Paediatric Laparoscopic Surgery with Caudal Block : A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To assess and compare Paediatric Quality of Recovery (PedSQoR) scores between 24 hours preoperatively(baseline) and 24 hours post-surgery among children receiving melatonin, midazolam, or play therapy preoperatively in addition to a standardized caudal block
研究概览
简要总结
This is a randomized, multiple-arm, parallel-group clinical trial comparing three different preoperative preparation methods—oral melatonin, intravenous midazolam, and non-drug play-based activities—in children undergoing laparoscopic abdominal surgery under general anesthesia with a caudal block. The main aim is to evaluate and compare the children’s quality of recovery after surgery using a validated pediatric recovery questionnaire. All participants will be randomly assigned to one of the three groups, receive the assigned intervention before surgery, and be monitored during and after the procedure at 24 and 48 hrs for recovery quality, comfort, and any side effects. This study will help identify which method best supports a smooth and comfortable recovery in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 5–15 years (either gender) ASA physical status 1-2 Scheduled for elective infra-umbilical laparoscopic abdominal surgery ( appendectomy, hernia repair, orchidopexy) Informed consent from parent/guardian and assent from child when appropriate.
排除标准
- •Known allergy to study drugs or local anesthetics Coagulopathy or local infection at block site Congenital spinal anomaly Significant cardiac conduction abnormality Developmental delay or cognitive impairment precluding questionnaire completion Obstructive sleep apnea requiring admission Active respiratory infection Anticipated need for postoperative ventilation.
结局指标
主要结局
To assess and compare Paediatric Quality of Recovery (PedSQoR) scores between 24 hours preoperatively(baseline) and 24 hours post-surgery among children receiving melatonin, midazolam, or play therapy preoperatively in addition to a standardized caudal block
时间窗: preoperatively- 24 hrs before surgery | postoperatively- 24 hrs after surgery
次要结局
- To assess the incidence of perioperative anxiety mYAPS score in each group before induction(PACU Face, Legs, Activity, Cry, & Consolability FLACC pain scores at arrival, 15, 30, 60 minutes)
研究者
Nishant Patel
AIIMS,New Delhi