Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06354699




Registration number
NCT06354699
Ethics application status
Date submitted
3/04/2024
Date registered
9/04/2024
Date last updated
9/04/2024

Titles & IDs
Public title
A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children
Scientific title
POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)
Secondary ID [1] 0 0
RGS0000003993
Universal Trial Number (UTN)
Trial acronym
POPSICLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Group Elective - Patient is undergoing a surgical procedure for circumcision, hypospadias, orchidopexy or laparoscopic appendicectomy.

Group Emergency - Patient is undergoing a surgical procedure for laparoscopic appendicectomy or scrotal exploration.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The prevalence of chronic post-surgical pain after 10- 12 months.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Identifying potential risk factors for chronic post-surgical pain
Timepoint [1] 0 0
12 months

Eligibility
Key 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)
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2028
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Telethon Kids Institute - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06354699
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Britta P von Ungern-Sternberg
Address 0 0
Telethon Kids Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06354699