Investigating chronic pain after surgery in children
POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)
Telethon Kids Institute · NCT06354699
This study looks at how often kids aged 0-16 have ongoing pain after surgery and what factors might contribute to it, to help doctors find ways to reduce this pain in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Telethon Kids Institute (other) |
| Locations | 16 sites (San Francisco, California and 15 other locations) |
| Trial ID | NCT06354699 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence, risk factors, and consequences of chronic post-surgical pain in children aged 0-16 years. It involves a multi-centre, international approach where participants will complete a series of questionnaires at various timepoints, starting before surgery and continuing up to one year post-surgery. The study focuses on common paediatric surgeries and evaluates factors such as anxiety and pain experiences that may contribute to chronic pain outcomes. The findings will help inform clinical practices to reduce the risk of chronic pain in children following surgery.
Who should consider this trial
Good fit: Ideal candidates are children aged 0-16 years undergoing specific elective or emergency surgical procedures.
Not a fit: Patients who do not speak English well enough to understand the questionnaires or have significant developmental delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved guidelines for managing post-surgical pain in children, enhancing their quality of life.
How similar studies have performed: While there have been studies on post-surgical pain in adults, this specific focus on children and the longitudinal approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The patient is undergoing a surgical procedure in either group elective (circumcision, hypospadias, orchidopexy, laparoscopic appendicectomy) or group emergency (laparoscopic appendicectomy, scrotal exploration) Exclusion Criteria: 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.
Where this trial is running
San Francisco, California and 15 other locations
- University of California — San Francisco, California, United States (NOT_YET_RECRUITING)
- Children's Hospital Colorado — Aurora, Colorado, United States (NOT_YET_RECRUITING)
- Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (NOT_YET_RECRUITING)
- Children's Hospital of Michigan — Detroit, Michigan, United States (NOT_YET_RECRUITING)
- Atrium Health-Wake Forest Baptist — Winston-Salem, North Carolina, United States (NOT_YET_RECRUITING)
- Children's Medical Center (Dallas) — Dallas, Texas, United States (NOT_YET_RECRUITING)
- Texas childrens hospital — Houston, Texas, United States (NOT_YET_RECRUITING)
- Townsville University hospital — Douglas, Queensland, Australia (NOT_YET_RECRUITING)
- Fiona Stanley Hospital — Perth, Western Australia, Australia (NOT_YET_RECRUITING)
- Telethon Kids Institute — Perth, Western Australia, Australia (RECRUITING)
- Flinders Medical Centre — Adelaide, Australia (NOT_YET_RECRUITING)
- Women 's and Children's Hospital — Adelaide, Australia (NOT_YET_RECRUITING)
- Royal Darwin Hospital — Tiwi, Australia (NOT_YET_RECRUITING)
- Hospital for Sick Children — Toronto, Canada (NOT_YET_RECRUITING)
- British Columbia Children's Hospital — Vancouver, Canada (NOT_YET_RECRUITING)
- Wellington Regional Hospital — Wellington, New Zealand (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Britta P von Ungern-Sternberg — Telethon Kids Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Pain, Chronic pain, Post-operative pain, Paediatric surgery