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

October 21, 2025 updated by: Telethon Kids Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Not yet recruiting
        • Flinders Medical Centre
        • Contact:
        • Principal Investigator:
          • Fiona Taverner
      • Adelaide, Australia
        • Not yet recruiting
        • Women 's and Children's Hospital
        • Principal Investigator:
          • Fiona Taverner
        • Contact:
      • Tiwi, Australia
        • Not yet recruiting
        • Royal Darwin Hospital
        • Contact:
        • Principal Investigator:
          • Edith Waugh
    • Queensland
      • Douglas, Queensland, Australia
    • Western Australia
      • Perth, Western Australia, Australia
        • Not yet recruiting
        • Fiona Stanley Hospital
        • Contact:
        • Principal Investigator:
          • Neil Hauser
      • Perth, Western Australia, Australia
        • Recruiting
        • Telethon Kids Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Britta von Ungern-Sternberg, Professor
        • Principal Investigator:
          • David Sommerfield, Associate
  • Canada
      • Toronto, Canada
        • Not yet recruiting
        • Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Jason Maynes
      • Vancouver, Canada
        • Not yet recruiting
        • British Columbia Children's Hospital
        • Contact:
        • Principal Investigator:
          • Gillian Lauder
  • New Zealand
      • Wellington, New Zealand
        • Not yet recruiting
        • Wellington Regional Hospital
        • Contact:
        • Principal Investigator:
          • Dan Frei
  • United States
    • California
      • San Francisco, California, United States, 94118
        • Not yet recruiting
        • University of California
        • Contact:
          • Jocelyn Wong
        • Principal Investigator:
          • Jocelyn Wong
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Melissa Brooks Peterson
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Lurie Children's Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Angelica Vargas
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Children's Hospital of Michigan
        • Contact:
        • Principal Investigator:
          • Angela Lindbloom
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Not yet recruiting
        • Atrium Health-Wake Forest Baptist
        • Contact:
        • Principal Investigator:
          • Thomas Templeton
    • Texas
      • Dallas, Texas, United States, 75235
        • Not yet recruiting
        • Children's Medical Center (Dallas)
        • Contact:
        • Principal Investigator:
          • Arul Lingappan
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Texas Childrens Hospital
        • Contact:
        • Principal Investigator:
          • Adam Adler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The participants will be the parents/legal guardians of children and the children themselves, aged 0-16 years old, undergoing planned or non-elective urgent surgical procedures.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The prevalence of chronic post-surgical pain after 10- 12 months.
Time Frame: 12 months
the prevalence of chronic post-surgical pain in paediatric patients after 10- 12 months.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Identifying potential risk factors for chronic post-surgical pain
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Telethon Kids Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Britta P von Ungern-Sternberg, Telethon Kids Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RGS0000003993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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