跳至主要内容
临床试验/NCT03912090
NCT03912090已完成不适用

Using, Efficacity and Safety of Intranasal Fentanyl for the Treatment of Acute Severe Pain on the Pediatric Emergency Department of Mercy Hospital.

Centre Hospitalier Régional Metz-Thionville1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2018年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
1
主要终点
Pain scale evolution

研究概览

简要总结

The treatment of acute severe pain in pediatric emergencies required a quick and effective therapeutic support. Actually in France, only peripheral venous access or oral therapies with onset of action are commonly used and only few treatments can be used to manage the acute severe pain in children. In June 2017, an intranasal fentanyl use protocol has been established in the pediatric emergency department of Mercy hospital-Metz. The intranasal fentanyl treatment has proved his effectiveness and safe condition in many countries since few years even though has not yet obtained a marketing authorization for use in children in France. In view of the information, parental permission was obtained before the intranasal administration. The efficacy and surveillance data in all patient records of children who benefited this analgesic protocol were retrospectively collected between June 2017 and August 2018. This retrospective study wants to describe the efficacy and safety of intranasal fentanyl on the pediatric emergency department.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who received fentanyl intranasal between june 2017 and august 2018

排除标准

  • Lack of surveillance data in the medical record of the patient

结局指标

主要结局

Pain scale evolution

时间窗: Day 1

Face Legs Activity Cry Consolability (FLACC) scale or Visual Analog Scale (VAS) FLACC scale involve, as its name implies, 5 items: face, legs, activity, cry and consolability with a score ranging from 0 to 2 each, knowing that 0 represents "no pain". The sum of each items is from 0 to 10, and 10 constitutes an intense pain. VAS is a 100-mm long horizontal line with verbal descriptors at each end to express the extremes of the feeling. Patients should mark the point on the line that the best correspond to their symptom severity. The patient's mark indicates pain severity and it's quantified by measuring the distance in millimeter from 0 (0 representes "no pain" and 100 represents "worst possible pain")

次要结局

  • Oxygen saturation(Day 1)
  • Respiratory frequency(Day 1)
  • Cardiac frequency(Day 1)
  • Glasgow Coma scale(Day 1)

研究者

发起方
Centre Hospitalier Régional Metz-Thionville
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Intranasal Fentanyl for the Treatment of Acute... | 临床试验