Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06354699 |
Other study ID # |
RGS0000003993 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 26, 2023 |
Est. completion date |
July 2028 |
Study information
Verified date |
April 2024 |
Source |
Telethon Kids Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.