Efficacy of Melatonin As an Analgesic in Preterm Neonate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluate the analgesic effect of melatonin in preterm
研究概览
简要总结
Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring Malondialdehyde (MDA), a well-accepted marker of oxidative stress, 60 minutes after the procedure.
详细描述
This is a randomized, double-blind, controlled trial
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infant
- •less than 37 weeks gestational age
- •who started enteral feeding.
排除标准
- •Multiple congenital anomalies.
- •Facial malformation.
- •Receiving analgesia or sedation.
- •Contraindication of enteral feeding.
- •Clinical or laboratory signs of sepsis.
- •Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.
研究组 & 干预措施
Melatonin group
Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.
干预措施: Melatonin 10 mg (Drug)
Placebo group
Preterm neonates will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.
干预措施: Placebo (Other)
结局指标
主要结局
Evaluate the analgesic effect of melatonin in preterm
时间窗: 5 minutes starting just before cannula insertion to 5 minutes after the procedure
Evaluate the analgesic effect of melatonin during venous cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Premature Infant pain Profile score (PIPP) scale 0-21, with 0-6 reflecting no pain, 6-12 reflecting mild-moderate pain, and above 12 indicating severe pain
Malondialdehyde (MDA), marker of oxidative stress
时间窗: 60 minutes of the procedure
Serum Malondialdehyde (MDA), a marker of oxidative stress through measuring serum MDA after 60 minutes of the procedure
次要结局
未报告次要终点