POPSICLE "Post-Operative Pain Study in Children – aLongitudinal Evaluation"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 试验地点
- 10
- 主要终点
- Primary outcome will be the prevalence of chronic post-surgical pain (CPSP) in paediatric patients
研究概览
简要总结
The POPSICLE study is an international observational longitudinal prospective cohort study across
several paediatric centres to assess the prevalence, risk factors, and consequences of persistent
pain following common paediatric surgeries.
The POPSICLE study will be led by Perth Children’s Hospital.
The objective of this project is to assess the prevalence, risk factors, and consequences of
persistent pain following common paediatric surgeries through a series of longitudinal prospective
cohorts across several paediatric centres.
Primary outcome will be the prevalence of chronic post-surgical pain (CPSP) in paediatric patients
at 10-12 months as defined by the ICD11 criteria.
Secondary endpoints will identify potential biopsychosocial risk factors contributing or maintaining
CPSP, such as parent or child anxiety, pre-existing and perioperative pain, acute postoperative
management, surgical factors, and to assess impacts on function one-year post surgery.
The study was designed to capture data over 10-12 months across multiple domains as recommended by PedIMMPACT (Pediatric Initiative on Methods, Measurement, and Pain
Assessment in Clinical Trials) including pain intensity; physical functioning; emotional functioning;
social functioning; pain interference and sleep.
Baseline and demographic characteristics will be summarized by standard descriptive summaries
(e.g. means and standard deviations for continuous variables such as age and percentages for
categorical variables such as gender). The majority of research into development of chronic pain
post-surgery has been conducted in major elective surgeries, in particular spinal fusion surgeries
and is in the order of 20%. Other common paediatric surgeries including those selected for this
project are less well studied e.g. 1-2 % in orchidopexy and 9% in some day case hernias. There is
also wide variation in prevalence of CPSP across surgeries in adults. Thus, it is difficult to estimate
a sample size. The aim is to collect data for at least 5000 children between the participating sites to be able to assess the incidence of chronic pain. This will also allow the assessment of the impact of anxiety on postoperative pain. Statistical power calculations will be conducted following the recruitment of 5000 children to confirm if the sample size is adequate and recruitment will be
continued as required.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 16.00 Year(s)（—）
- 性别
- All
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)
- •Patient is aged between 1-16 years old.
排除标准
- •The parent and child have inadequate English or local language skills to understand the questionnaires.
- •2.Children with significant/severe developmental or cognitive delay based on a formal diagnosis.
- •3.Families that are unable to complete the long-term follow up surveys.
结局指标
主要结局
Primary outcome will be the prevalence of chronic post-surgical pain (CPSP) in paediatric patients
时间窗: One year follow up
at 10-12 months as defined by the ICD11 criteria
时间窗: One year follow up
次要结局
- Secondary endpoints will identify potential biopsychosocial risk factors contributing or maintaining(CPSP, such as parent or child anxiety, pre-existing and perioperative pain, acute postoperative)