Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates : A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- procedural pain managment
研究概览
简要总结
Pain in neonatal life has profound long-term developmental impacts, so pain control is crucial. The intranasal (IN) route is a minimally invasive method for rapidly delivering fentanyl to provide short-term analgesia and sedation in adults and pediatrics, but few data exist about its use in neonates. Meanwhile, intravenous fentanyl is widely used in sedation and pain management.
Using intranasal fentanyl as an analgesic in preterm neonates may provide a rapid, effective, noninvasive route for administration.
详细描述
The aim of this study is to evaluate the effect of intranasal fentanyl versus the intravenous route for procedural pain management in preterm neonates as assessed by pain scoring system before and after the procedure.
Enrolled neonates will be allocated randomly to one of the three groups during painful procedure, using single blinded method, as scoring will occur by a different physician than the researcher.
Atomizer group: will receive intranasal fentanyl (@fentanyl hamein 50 mcg/1 ml, manufactured by Sunny Pharmaceutical) using a nasal atomizer; the dose of INF is 1.5 µg/kg/dose.
Direct nasal group: will receive intranasal fentanyl directly installed into the nostrils with the same dose.
Typically, one dose is given during the procedure; after 5 minutes, a second dose could be administered based on the clinical assessment (maximum two doses per procedure), with reassessment of the pain score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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 neonates with gestational age between 28 and 36 weeks gestation.
- •Undergoing painful procedures such as central venous access insertion, elective endotracheal intubation, and lumbar puncture.
排除标准
- •known contraindications for fentanyl use, such as fentanyl hypersensitivity and liver failure.
- •Known contraindication for intranasal administration of drugs (choanal atresia, nasal mucosal erosion, and epistaxis)
- •Post-surgical patients.
- •Patients sedated by fentanyl infusion / midazolam infusion.
- •Evidence of neurological disease with disturbed conscious level, such as intraventricular hemorrhage grade III or IV, hypoxic ischemic encephalopathy, or inborn error of metabolism.
研究组 & 干预措施
intravenous group
this group of neonates will recieve intravenous fentanyl during procedure
干预措施: fentanyl intravenous (Drug)
direct intranasal group
this group of neonates will recieve direct intranasal fentanyl during procedure
干预措施: fentanyl intranasal direct (Drug)
nasal atomizer group
this group of neonates will recieve intranasal fentanyl with atomizer during procedure
干预措施: Fentanyl intranasal using atomizer (Drug)
结局指标
主要结局
procedural pain managment
时间窗: from giving the fentanyl before the procedure till one hour after .
The efficacy of different modalities of intranasal fentanyl, either nasal atomizer or direct method, versus intravenous administration in neonatal pain management using Premature Infant Pain Profile (PIPP) scale before and after the administration. PIPP score ranges from 0 to 21, A PIPP score of 0-6 suggests minimal or no pain, 7-12 indicates moderate pain and a score ≥ 13 is interpreted as severe pain.
次要结局
未报告次要终点