Comparison Between Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Emergence agitation
研究概览
简要总结
This study aims to compare the efficacy of using oral Melatonin versus nebulized Dexmedetomidine in limitation of emergence agitation in children undergoing adenotonsillectomy.
详细描述
Adenotonsillectomy is one of the most commonly performed surgical procedures in children with high incidence of emergence agitation about 80% and high degree of post operative pain.
Oral midazolam, a short-acting benzodiazepine, is commonly used as a standard premedication in children due to its well-established anxiolytic, sedative, and amnestic effects. It works by enhancing GABAergic neurotransmission in the central nervous system, helping reduce anxiety and facilitating a smoother anesthetic induction and emergence.
Dexmedetomidine is a centrally acting α-2 adrenergic agonist with sedative, hypnotic, analgesic, anxiolytic, anti-sialagogue, antinociceptive and sympatholytic action.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 3 and 7 years.
- •Both sexes.
- •Classified as American Society of Anesthesiologists (ASA) physical status I or II according to the American Society of Anesthesiologists.
- •Scheduled for elective adenotonsillectomy under general anesthesia.
排除标准
- •Parental refusal to participate in the study.
- •Known allergy or hypersensitivity to dexmedetomidine, melatonin or midazolam.
- •Presence of developmental delay.
- •Central nervous system disorders.
- •Intellectual disability (formerly termed mental retardation).
- •Neurological or psychiatric conditions associated with anxiety or agitation (e.g., cerebral palsy, epilepsy, separation anxiety disorder, attention-deficit/hyperactivity disorder).
- •Current or recent treatment with anticonvulsants or sedative medications
研究组 & 干预措施
Group C (Control Group)
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.5 mg/kg of midazolam dissolved in Apple Juice.
干预措施: Normal saline (Drug)
Melatonin Group
Participants will receive placebo nebulizer (3 ml of normal saline) without drug and 0.2 mg/kg of oral melatonin syrup.
干预措施: Oral melatonin syrup (Drug)
Dexmedetomidine Group
Participants will receive placebo syrup (Apple Juice) and 2 µ/kg nebulized dexmedetomidine prepared in 0.9% normal saline to a final volume of 3ml.
干预措施: Nebulized dexmedetomidine (Drug)
结局指标
主要结局
Emergence agitation
时间窗: 30 minutes after recovery
Emergence agitation will be assessed by using Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable score is 20. A score of ≥10 has 64% sensitivity and 86% specificity for the diagnosis of Emergence Agitation (ED). A score of \>12 has 100% sensitivity and 94.5% specificity for the diagnosis of ED.
次要结局
- Perioperative anxiety(During transferring to operating room (Up to 30 minutes).)
- Mask tolerance(Intraoperatively)
- Degree of pain(Before home discharge (Up to 6 hours))
- Total postoperative analgesics consumption(Before home discharge (Up to 6 hours))
研究者
Amany Abd Elsamd Kamel Eid
Assistant Lecturer of Anesthesia, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.
Tanta University