Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- The efficacy of postoperative sedation according to pain score.
研究概览
简要总结
Newborn infants experience pain after surgical procedures,prevention and management of pain in neonates is important due to its deleterious consequences. Fentanyl is a widely used analgesic which promotes rapid analgesia,however, is not free of adverse effects including chest wall rigidity, hypothermia, hypotension, respiratory depression and tolerance.Dexmedetomidine is a selective α 2-adrenergic agonist can cause sedation, anxiolysis, analgesia and minimal respiratory depression.Therefore, the objective of the study is to evaluate the safety and efficacy of dexmedetomidine compared to fentanyl in postoperative mechanically ventilated neonates.
详细描述
A prospective, randomized trial, which was conducted upon neonates who needed postoperative mechanical ventilation in Neonatal Intensive Care Unit, Mansoura University Children's Hospital.The patients were randomized to two groups according to the drug they received for postoperative sedation. The first group received dexmedetomidine infusion and the second group received fentanyl infusion.Our primary outcome was the efficacy of postoperative sedation score, and the secondary outcomes were plasma cortisol level, time to extubation, time to reach 100ml/kg enteral feed, need for adjuvant sedative and skeletal muscle relaxant, length of the hospital stay, side effects of sedative drugs and mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates need postoperative ventilation.
排除标准
- •Major congenital cardiovascular anomalies.
- •Chromosomal anomalies.
- •Grade IV intraventricular hemorrhage.
- •Tracheoesophageal fistula with wide gap (distance between proximal and distal end more than two centimeters).
研究组 & 干预措施
Fentanyl
Neonates received fentanyl infusion during postoperative phase.
干预措施: Fentanyl (Drug)
Dexmedetomidine
Neonates received dexmedetomidine infusion during postoperative phase.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The efficacy of postoperative sedation according to pain score.
时间窗: upto five days after surgical intervention
Assessment of Neonatal Pain, Agitation and Sedation Scale immediately after the operations then every 12 hours till 5 days
次要结局
- Plasma cortisol level(Within 48 hours after surgical intervention)
- Need of adjuvant analgesics or sedatives(upto five days after surgical intervention)
- Need of skeletal muscle relaxant(upto five days after surgical intervention)
- Time to extubation.(upto 21 days postoperative)
- Length of hospital stay.(upto 30 days postoperative)
- Mortality(upto 21 days postoperative)
- Adverse effects of the sedative drugs(upto seven days after surgical intervention)
- Time to reach 100ml/kg/day enteral feed.(upto 21 days postoperative)
- Culture-proven sepsis(upto 30 days after surgical intervention)