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