NCT06354699

A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Telethon Kids Institute · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Pain

Timeline

• Start date: 2023-06-26
• Primary completion: 2028-06-01
• Completion: 2028-07-01
• First posted: 2024-04-09
• Last updated: 2025-10-23

Locations

16 sites across 4 countries: United States, Australia, Canada, New Zealand