Effect of Preoperative Oral Melatonin on Emergence Agitation Following Pediatric Tonsillectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale
研究概览
简要总结
The goal of this clinical trial is to learn if melatonin can decrease emergence agitation in pediatric post tonsillectomy. The main questions it aims to answer are:
Does melatonin decrease emergence agitation in pediatric post tonsillectomy? What medical problems do participants have when taking melatonin? Researchers will compare melatonin to a placebo (a look-alike substance that contains no drug) to see if melatonin works todecrease emergence agitation in pediatric post tonsillectomy
Participants will receive Oral melatonin at a dose of 0.5 mg/kg (maximum 20 mg) administered 30 minutes before induction of anesthesia. Dose chosen based on prior pediatric studies and safety data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Parent/legal guardian provides written informed consent
排除标准
- •• Known allergy or contraindication to melatonin.
- •Pre-existing neurological or psychiatric disorders (e.g., epilepsy, autism, ADHD).
- •Children receiving any sedative or psychoactive medication within 48 hours of surgery.
- •Emergency surgery or any procedure other than tonsillectomy/adenoidectomy.
- •Children with known sleep disorders or those taking melatonin supplements.
- •Developmental delay, neurologic disorders, sleep disorders, or known obstructive sleep apnea requiring ICU postoperatively.
- •Hepatic or renal dysfunction (ALT/AST >2×ULN, Cr >1.5 mg/dL)
研究组 & 干预措施
Group P (Placebo Group)
干预措施: Placebo (Drug)
Group M (Melatonin Group)
干预措施: Melatonin (Drug)
结局指标
主要结局
Incidence and Severity of Emergence Agitation (EA): EA will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale
时间窗: 5, 10, 15, and 30 minutes after arrival in the PACU.
The PAED scale consists of five items (eye contact, awareness of surroundings, purposeful actions, restlessness, and inconsolability), each scored from 0 to 4. Total score ranges from 0 to 20., scale ≥10 or equivalent define the presence of clinically significant EA
次要结局
- Time to Discharge(10-30 min from arriving to PACU)
- Postoperative Pain(first 2 hours postoperative)
- Rescue Analgesia(24 hours after surgery)
- Adverse Events(first 24-hour post operative)
- Parent/caregiver satisfaction(first 24-hour post operative)
研究者
Taghreed Elshahat Sakr
lecturer of anesthesia and icu
Benha University