跳至主要内容
临床试验/NCT02125201
NCT02125201已完成4 期

Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Intravenous Fentanyl 1-1.5 mcg/kg

干预措施: Fentanyl (Drug)

intranasal fentanyl

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peniakov Marina

Doctor

HaEmek Medical Center, Israel

研究点 (1)

Loading locations...

相似试验