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

T

Telethon Kids Institute

Status

Enrolling

Conditions

Chronic Pain

Study type

Observational

Funder types

Other

Identifiers

NCT06354699
RGS0000003993

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,000 estimated patients

Sex

All

Ages

Under 16 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

5,000 participants in 2 patient groups

Group Elective
Description:
Patient is undergoing a surgical procedure for circumcision, hypospadias, orchidopexy or laparoscopic appendicectomy.
Group Emergency
Description:
Patient is undergoing a surgical procedure for laparoscopic appendicectomy or scrotal exploration.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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