Chronic PainPOPSICLENCT06354699
A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children
An observational study of Chronic Pain, run by Telethon Kids Institute at 16 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- How many people
- 5,000 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 26 Jun 2023to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- The patient is undergoing a surgical procedure in either group elective (circumcision, hypospadias, orchidopexy, laparoscopic appendicectomy) or group emergency (laparoscopic appendicectomy, scrotal exploration)
Who cannot join
- 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.
Trial locations and contacts
16 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 4 countries
United States7 sites, 7 recruiting
- Not yet recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Melissa Brooks Peterson, +13035067817, melissa.brooks@childrenscolorado.org
Melissa Brooks Peterson
- Not yet recruiting
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Angelica Vargas, avargas@luriechildrens.org
Angelica Vargas
- Not yet recruiting
Children's Medical Center (Dallas)
Dallas, Texas, 75235
Arul Lingappan, +18325245242, arul.lingappan@utsouthwestern.edu
Arul Lingappan
- Not yet recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Angela Lindbloom, 3137454049, alindblo@dmc.org
Angela Lindbloom
- Not yet recruiting
Texas childrens hospital
Houston, Texas, 77030
Adam Adler, 17864177529, adamcadler@gmail.com
Adam Adler
- Not yet recruiting
University of California
San Francisco, California, 94118
Jocelyn Wong
Jocelyn Wong
- Not yet recruiting
Atrium Health-Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Thomas Templeton, +13367168791, ttemplet@wakehealth.edu
Thomas Templeton
Australia6 sites, 6 recruiting
- Not yet recruiting
Flinders Medical Centre
Adelaide
Fiona Taverner, 0418214442, fiona.taverner@sa.gov.au
Fiona Taverner
- Not yet recruiting
Women 's and Children's Hospital
Adelaide
Fiona Taverner, 0418 214 442, fiona.taverner@sa.gov.au
Fiona Taverner
- Not yet recruiting
Townsville University hospital
Douglas, Queensland
Priya Sreedharan, 744331111, subhapriya.sreedharan@health.qld.gov.au
Priya Sreedharan
- Not yet recruiting
Fiona Stanley Hospital
Perth, Western Australia
Neil Hauser, 0438094395, neil.hauser@health.wa.gov.au
Neil Hauser
- Recruiting
Telethon Kids Institute
Perth, Western Australia
Natalie P Jowett, 08 6456 4809, Natalie.Jowett@telethonkids.org.au
Lliana Slevin, 08 64564806, Lliana.slevin@telethonkids.org.au
- Not yet recruiting
Royal Darwin Hospital
Tiwi
Edith Waugh, 498002564, Edith.Waugh@nt.gov.au
Edith Waugh
Canada2 sites, 2 recruiting
- Not yet recruiting
Hospital for Sick Children
Toronto
Jason Maynes, 04168135934, jason.maynes@sickkids.ca
Jason Maynes
- Not yet recruiting
British Columbia Children's Hospital
Vancouver
Gillian Lauder, 60587523455955, glauder@cw.bc.ca
Gillian Lauder
New Zealand1 site, 1 recruiting
- Not yet recruiting
Wellington Regional Hospital
Wellington
Dan Frei, daniel.frei@ccdhb.org.nz
Dan Frei
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Post-operative pain, Paediatric surgery
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start26 Jun 2023
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Britta P von Ungern-Sternberg, Principal investigator, Telethon Kids Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354699
- Sponsor's protocol ID
- RGS0000003993
- Acronym
- POPSICLE
- Status last verified
- Oct 2025
- First submitted
- 3 Apr 2024
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)
- ClinicalTrials.gov ID
- NCT06354699
- Acronym / sponsor ID
- POPSICLE / RGS0000003993
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Post-operative pain, Paediatric surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- The patient is undergoing a surgical procedure in either group elective (circumcision, hypospadias, orchidopexy, laparoscopic appendicectomy) or group emergency (laparoscopic appendicectomy, scrotal exploration)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Identifying potential risk factors for chronic post-surgical pain
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Britta P von Ungern-Sternberg principal investigator
Telethon Kids Institute
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Telethon Kids Institute at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of chronic post-surgical pain after 10- 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.