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临床试验/NCT06035042
NCT06035042已完成不适用

4P: Persistent Postoperative Pediatric Pain

Region Halland5 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
5
主要终点
Adherence to guidelines from ESPA regarding perioperative analgesia

研究概览

简要总结

For children, adequate perioperative pain management is a right according to the UN convention on the rights of the child, a law in Sweden since 2020. Despite this, children are still under-treated in many cases. In addition to great suffering, this can lead to missing school and a long-term burden on the society.

ESPA, the European Society for Pediatric Anesthesia, has drawn up guidelines for perioperative pain management. With the study 4P: Persistent Postoperative Pediatric Pain, we want to investigate whether these guidelines are followed and how many children develop long-term pain postoperatively.

In order to map the prevalence of pain after surgery in children in Sweden, the investigators plan to include and follow 2000 children in southern Sweden who undergo surgery. The study provides a unique opportunity to follow a large number of children, evaluate given per- and postoperative pain treatment and identify factors linked to the development of acute and long-term postoperative pain. Our goal is to optimize peri- and postoperative pediatric pain management to promote rapid recovery after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 1-17 years
  • Scheduled surgery for hernia, penile surgery, retentio testis, adenotonsillectomy, appendectomy or acute fracture in southern Sweden.
  • Informed consent

排除标准

  • Scheduled for several surgeries within the time-frame
  • Inability to understand swedish
  • Inability to understand the meaning of participation.

结局指标

主要结局

Adherence to guidelines from ESPA regarding perioperative analgesia

时间窗: Perioperative

How many patients are treated according to the suggested guidelines regarding pain treatment from ESPA (%)? Do they experience less postoperative pain (FLACC/FPS/NRS 0-10)? Groups compared with MannWhitney U-test. Also description of the deviation.

Incidence of acute postoperative pain

时间窗: Within 24 hours after surgery

How many children experience acute postoperative pain after surgery in Sweden?

Incidence of persistent postoperative pain

时间窗: At 1 year after surgery

How many children experience persistent postoperative pain after surgery in Sweden?

Incidence of persistent postoperative pain

时间窗: At 3 months after surgery

How many children experience persistent postoperative pain after surgery in Sweden?

Incidence of persistent postoperative pain

时间窗: At 6 months after surgery

How many children experience persistent postoperative pain after surgery in Sweden?

次要结局

  • Gender(Acute (24 hours) and persistent (3,6 months and 1 year))
  • Parental stress(3 months after surgery)
  • Do regional blocks influence the level of acute postoperative pain?(Acute - within 24 hours.)
  • Do regional blocks influence the level of persistent pain?(3 months after surgery)
  • Age(Acute (24 hours) and persistent (3,6 months and 1 year))
  • Parental stress(Within 24 hours)

研究者

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

Anna Persson

Consultant in Anaesthesia and Intensive Care Medicine, PhD

Region Halland

研究点 (5)

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