MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 676
- 试验地点
- 2
- 主要终点
- Incidence of emergence agitation
研究概览
简要总结
Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 1-6 years
- •Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia
排除标准
- •Any known allergy or contraindication to study treatment or excipåients
- •Current daily medication with melatonin
研究组 & 干预措施
Placebo
Participants receive isotonic sodium chloride (9mg/mL) intravenously once approximately 30 minutes before end of surgical procedure in a volume equivalent to the melatonin group for the same weight.
干预措施: Isotonic sodium chloride solution (Drug)
Melatonin
Participants receive melatonin solution for injection 1 mg/mL in a dosage of 0.15 mg/kg body weight as a single intravenous injection approximately 30 minutes before end of surgical procedure.
干预措施: Melatonin (Drug)
结局指标
主要结局
Incidence of emergence agitation
时间窗: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
Participants will be assessed on Watcha scale repeatedly ever 15 min during their stay at the Post-Anesthetic Care Unit. The variable is dichotomous: any score \>2= "Yes" and no score \<=2 = "No"
次要结局
- Opioid consumption(Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).)
- Non-serious Adverse Events (AE)(From enrolment to the trial until 24-hour follow-up.)
研究者
Arash Afshari
Head of Research, Associated Professor
Rigshospitalet, Denmark