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

Chronic Pain Clinical Trial

— POPSICLE  

Official title:

POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354699
• Other study ID #: RGS0000003993
• Status: Recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Locations

Country	Name	City	State
Australia	Telethon Kids Institute	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Telethon Kids Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of chronic post-surgical pain after 10- 12 months.	the prevalence of chronic post-surgical pain in paediatric patients after 10- 12 months.	12 months
Secondary	Identifying potential risk factors for chronic post-surgical pain	Identify potential biopsychosocial risk factors contributing or maintaining chronic post-surgical pain including parent and child anxiety, pre-existing and perioperative pain experience, acute postoperative management, surgical factors and to assess impacts on function one-year post surgery.	12 months