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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
Titles & IDs
Public title
A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children
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Scientific title
POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)
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Secondary ID [1]
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RGS0000003993
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Universal Trial Number (UTN)
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Trial acronym
POPSICLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Pain
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Condition category
Condition code
Neurological
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Other neurological disorders
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Musculoskeletal
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The prevalence of chronic post-surgical pain after 10- 12 months.
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Assessment method [1]
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the prevalence of chronic post-surgical pain in paediatric patients after 10- 12 months.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Identifying potential risk factors for chronic post-surgical pain
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Assessment method [1]
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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.
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Timepoint [1]
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12 months
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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)
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Minimum age
No limit
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2028
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Telethon Kids Institute - Perth
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Recruitment postcode(s) [1]
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- Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Telethon Kids Institute
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06354699
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Britta P von Ungern-Sternberg
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Address
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Telethon Kids Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06354699