A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: up to 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, New Zealand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)
Overview
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.
Primary outcome measures
- The prevalence of chronic post-surgical pain after 10- 12 months. [Time frame: 12 months]
Secondary outcome measures (1)
- Identifying potential risk factors for chronic post-surgical pain [Time frame: 12 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- University of California — San Francisco
- Children's Hospital Colorado — Aurora
- Lurie Children's Hospital of Chicago — Chicago
- Children's Hospital of Michigan — Detroit
- Atrium Health-Wake Forest Baptist — Winston-Salem
- Children's Medical Center (Dallas) — Dallas
- Texas childrens hospital — Houston
Australia · 6 centers
- Townsville University hospital — Douglas
- Fiona Stanley Hospital — Perth
- Telethon Kids Institute — Perth
- Flinders Medical Centre — Adelaide
- Women 's and Children's Hospital — Adelaide
- Royal Darwin Hospital — Tiwi
Canada · 2 centers
- Hospital for Sick Children — Toronto
- British Columbia Children's Hospital — Vancouver
New Zealand · 1 center
- Wellington Regional Hospital — Wellington
Identifiers
NCT: NCT06354699 · RGS0000003993