跳至主要内容
临床试验/NCT06354699
NCT06354699招募中不适用

POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)

Telethon Kids Institute16 个研究点 分布在 4 个国家目标入组 5,000 人开始时间: 2023年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
16
主要终点
The prevalence of chronic post-surgical pain after 10- 12 months.

研究概览

简要总结

The purpose of this study is to investigate the prevalence, risk factors and consequences of chronic post-surgical pain in children aged 0-16 years through a number of questionnaires completed at various timepoints, from before surgery up to 1 year post surgery.

详细描述

The POPSICLE study is a multi-centre, international research study that will investigate the prevalence, risk factors and consequences of chronic post-surgical pain (CPSP) in children 0-16 years undergoing the following common paediatric surgeries: laparoscopic appendicectomy, scrotal exploration, orchidopexy, hypospadias repair and circumcisions. CPSP as well as risk factors and their association with chronic pain, including parent and child anxiety, pre-existing pain, peri-operative pain experience and acute post-operative management, will be assessed through a series of longitudinal questionnaires at 6 timepoints from pre-surgery to 10-12 months post-surgery. Baseline measures will be completed pre-operatively and post-surgery measures of pain and function will be undertaken at Day 2, 3-4 weeks, 3-4 months and 10-12 months post-operatively.

Chronic pain has a significant effect on children's quality of life, negatively impacting their physical, emotional and social health as well as schooling. Additionally, adolescent chronic pain is associated with higher rates of depression, anxiety, feeling of helplessness and lack of autonomy compared to healthy children. Therefore, evidence-based knowledge from this research will inform perioperative practice minimising the risk of a child going on to develop chronic post-surgical pain. This will benefit the child, their family and the healthcare system by aiding in the formulation of practice guidelines to follow high risk children more closely to treat any potential persistent pain earlier to avoid the development of chronic pain.

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
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The patient is undergoing a surgical procedure in either group elective (circumcision, hypospadias, orchidopexy, laparoscopic appendicectomy) or group emergency (laparoscopic appendicectomy, scrotal exploration)

排除标准

  • The parent and child have inadequate English language skills to understand the questionnaires
  • Children with significant/severe developmental or cognitive delay based on a formal diagnosis.
  • Families that are unable to complete the long-term follow up surveys.

结局指标

主要结局

The prevalence of chronic post-surgical pain after 10- 12 months.

时间窗: 12 months

the prevalence of chronic post-surgical pain in paediatric patients after 10- 12 months.

次要结局

  • Identifying potential risk factors for chronic post-surgical pain(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (16)

Loading locations...

相似试验

A Longitudinal Study Looking at the Prevalence, Risk... | 临床试验