Dexmedetomidine as an Adjunct to Fentanyl for Analgesia and Sedation of Term Neonates on Mechanical Ventilation
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
- need for additional rescue analgesia
研究概览
简要总结
Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation.
In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine
详细描述
Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation. Opioids, such as fentanyl, are frequently used for analgesia and sedation in mechanically ventilated neonates with their short- and long-term adverse consequences Dexmedetomidine (DEX) is a specific alpha2 adrenergic agonist with promising data in NICU. Data exist that Dexmedetomidine recipient neonates require less adjunct sedation, experience less respiratory depression, less clinically significant hemodynamic effects, quicker establishment of enteral feeds and they could be extubated whilst on Dexmedetomidine infusion.
In the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term neonates (≥ 37 weeks gestational age)
- •Age: 1 to 28 days.
- •Neonates just started invasive mechanical ventilation and are going to start sedation.
排除标准
- •Presence of central nervous system abnormality
- •Complex multiple congenital anomalies
- •Neonates with facial malformations
- •Neonates on mechanical Ventilation setting (peep above 9)
研究组 & 干预措施
dexmedetomidine and fentanyl
fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates <14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age
干预措施: Dexmedetomidine (Drug)
dexmedetomidine and fentanyl
fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates <14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age
干预措施: fentanyl 0.5 mcg/kg/hr (Drug)
fentanyl only
fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24
干预措施: fentanyl 1mcg/kg/hr (Drug)
结局指标
主要结局
need for additional rescue analgesia
时间窗: 24 hours
number of doses of rescue analgesia given during the first 24 hours
NPASS ( neonatal pain , agitation and sedation score)
时间窗: 24 hours
done hourly to indicate pain and sedation if more than or equal to three patient is in pain
次要结局
- development of bradycardia,(24 hours)
- development of hypotension(24 hours)
- development of respiratory depression(24 hours)
研究者
Mariam Ibrahim
assistant professor
Ain Shams University