Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354699
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-03
Brief Title:
A Longitudinal Study Looking at the Prevalence Risk Factors Consequences of Persistent Post-surgical Pain in Children
Sponsor:
Telethon Kids Institute
Organization:
Telethon Kids Institute
Study Overview
Official Title:
POPSICLE Postoperative Pain Study in Children - a Longitudinal Evaluation
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPSICLE
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 childrens 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
Chronic pain has a significant effect on childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None