跳至主要内容
临床试验/NCT06489327
NCT06489327
招募中
不适用

Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial

Al-Azhar University4 个研究点 分布在 2 个国家目标入组 120 人2026年7月12日

概览

阶段
不适用
干预措施
melatonin (Circadin ®) 0.2 mg/kg
疾病 / 适应症
Preoperative Anxiety
发起方
Al-Azhar University
入组人数
120
试验地点
4
主要终点
preoperative anxiety
状态
招募中
最后更新
3个月前

概览

简要总结

Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety.

In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance.

Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.

注册库
clinicaltrials.gov
开始日期
2026年7月12日
结束日期
2026年12月15日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Al-Azhar University

入排标准

入选标准

  • Patients of either sex
  • age from 4 to 14 years
  • Patients with American society Anesthesiologist physical status I and II
  • Patients undergoing elective surgeries

排除标准

  • ASA more than III
  • Drug allergy.
  • Gastrointestinal disorders.

研究组 & 干预措施

1st group: melatonin 0.2 mg/kg group

patients will receive oral melatonin at a dose of 0.2 mg/kg

干预措施: melatonin (Circadin ®) 0.2 mg/kg

2nd group: M04 groupmelatonin 0.4 mg/kg group

patients will receive oral melatonin at a dose of 0.4 mg/kg

干预措施: melatonin (Circadin ®) 0.4 mg/kg

3rd group: placebo group

patients will receive oral placebo premedication

干预措施: placebo group

结局指标

主要结局

preoperative anxiety

时间窗: 24 hours

The child's anxiety level will be assessed by Visual analogue scale-anxiety (VAS-A). The VAS-A consists of a 100 mm horizontal line; the left edge of the line is marked as "calm," while the other end shows "maximum anxiety." The patients were asked to assess their own anxiety and mark it on the anxiety line.

次要结局

  • preoperative sedation(24 hours)

研究点 (4)

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