Clinical trial NCT06354699: A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children
Official title: POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: Chronic pain
Post-operative pain
Paediatric surgery
Lead sponsor: Telethon Kids Institute
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 5000
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be the parents/legal guardians of children and the children themselves, aged 0-16 years old, undergoing planned or non-elective urgent surgical procedures.

Brief 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.

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.

Primary outcomes:
measure: The prevalence of chronic post-surgical pain after 10- 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Identifying potential risk factors for chronic post-surgical pain
timeFrame: 12 months
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Telethon Kids Institute
state: Western Australia
Study officials:
affiliation: Telethon Kids Institute
name: Britta P von Ungern-Sternberg
role: PRINCIPAL_INVESTIGATOR
References: