Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pain scale - N-PASS
研究概览
简要总结
Neonatal intensive care unit patients undergoes many painful procedures during their hospitalization. Effective pain control in such procedures as intubation, catheterization, central line insertion, chest tube insertion, etc. is an important part of treatment. Opioids administration is a common practice for acute pain prevention. Fentanyl is the preferred opioid due to it rapid onset and short duration of action.
Fentanyl may be given intravenously, transcutaneous transmucosal and intranasal. Intranasal administration is practiced for about 20 years. A rich vascular supply in a nose provides rapid absorption of the drug. This uninvasive root is now popular for pain prevention and treatment. There are about 20 trials with intranasal fentanyl administration to children from 6 month old to 18 years. The investigators did not find information about this way of administration in neonates.
In our pilot study the investigators want to check if intranasal administration of fentanyl is safe and effective in pain prevention in term and preterm neonates during invasive procedures and to compare it with intravenous route of administration.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term and preterm neonates that require invasive procedures (elective or semielective intubation, central line insertion , chest drain or abdominal drain)
排除标准
- •Neonates with prolonged analgesic treatment before the procedure
- •Neonates with neurologic problem which can interact with pain assessment
研究组 & 干预措施
intravenous fentanyl
Intravenous Fentanyl 1-1.5 mcg/kg
干预措施: Fentanyl (Drug)
intranasal fentanyl
Intranasal Fentanyl 1.5-2 mcg/kg
干预措施: Fentanyl (Drug)
结局指标
主要结局
Pain scale - N-PASS
时间窗: before the intervention and till one our after intervention
次要结局
未报告次要终点
研究者
Peniakov Marina
Doctor
HaEmek Medical Center, Israel
