Actively Recruiting
POPSICLE (Postoperative Pain Study in Children) A Longitudinal Evaluation of Chronic Post-Surgical Pain in Children 0-16 Years
Led by Telethon Kids Institute · Updated on 2025-10-23
5000
Participants Needed
16
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying chronic post-surgical pain (CPSP) in children aged 0 to 16 years who undergo common pediatric surgeries such as laparoscopic appendicectomy, scrotal exploration, orchidopexy, hypospadias repair, and circumcision. The study aims to understand how often CPSP occurs, its risk factors, and its effects on children's physical, emotional, and social well-being. This observational study will collect information through questionnaires from before surgery up to one year after surgery. Participants will be grouped based on the type of surgery they receive: elective surgeries including circumcision, hypospadias repair, orchidopexy, or laparoscopic appendicectomy, and emergency surgeries including laparoscopic appendicectomy or scrotal exploration. The study observes these groups without providing treatments, focusing on collecting data about their pain experiences and related factors over time. Children and their families will complete questionnaires at six different times: before surgery, on Day 2 after surgery, at 3 to 4 weeks, 3 to 4 months, and 10 to 12 months post-surgery. These questionnaires assess pain levels, function, anxiety, and other factors. Researchers will track the prevalence of chronic post-surgical pain at 10 to 12 months and identify potential risk factors to help improve future care and guidelines for children at risk of long-term pain.
CONDITIONS
Brief Title
A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The child is undergoing one of these surgical procedures: circumcision, hypospadias repair, orchidopexy, laparoscopic appendicectomy, or scrotal exploration
You will not qualify if you...
- Parent and child do not have sufficient English language skills to understand the questionnaires
- Child has a formal diagnosis of significant or severe developmental or cognitive delay
- Family is unable to complete long-term follow-up surveys
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or remote)
Duration - Up to 1 week before surgery
Participants complete baseline questionnaires before surgery to assess pre-operative pain and risk factors.
1 baseline visit (in-person or remote)
Duration - Day of surgery to 2 days post-surgery
Participants undergo their planned surgical procedure and immediate post-operative pain assessments.
1 surgical visit and 1 post-operative visit on Day 2
Duration - 3-4 weeks to 10-12 months post-surgery
Participants complete pain and function questionnaires at multiple timepoints to monitor recovery and chronic pain development.
3 follow-up visits at 3-4 weeks, 3-4 months, and 10-12 months post-surgery
Trial Site Locations
Total: 16 locations
1
University of California
San Francisco, California, United States, 94118
Not Yet Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Not Yet Recruiting
4
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Not Yet Recruiting
5
Atrium Health-Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Not Yet Recruiting
6
Children's Medical Center (Dallas)
Dallas, Texas, United States, 75235
Not Yet Recruiting
7
Texas childrens hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
8
Townsville University hospital
Douglas, Queensland, Australia
Not Yet Recruiting
9
Fiona Stanley Hospital
Perth, Western Australia, Australia
Not Yet Recruiting
10
Telethon Kids Institute
Perth, Western Australia, Australia
Actively Recruiting
11
Flinders Medical Centre
Adelaide, Australia
Not Yet Recruiting
12
Women 's and Children's Hospital
Adelaide, Australia
Not Yet Recruiting
13
Royal Darwin Hospital
Tiwi, Australia
Not Yet Recruiting
14
Hospital for Sick Children
Toronto, Canada
Not Yet Recruiting
15
British Columbia Children's Hospital
Vancouver, Canada
Not Yet Recruiting
16
Wellington Regional Hospital
Wellington, New Zealand
Not Yet Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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