[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06354699":3,"trial-entities:NCT06354699":264,"trial-summary:NCT06354699":268},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":31,"secondary_outcomes":36,"sex":40,"minimum_age":25,"maximum_age":41,"healthy_volunteers":42,"eligibility_criteria":43,"std_ages":47,"locations":49,"central_contacts":258,"overall_officials":259,"references":262,"see_also_links":263},"NCT06354699","RGS0000003993","A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children","POPSICLE (Postoperative Pain Study in Children - a Longitudinal Evaluation)","RECRUITING","2028-07","2025-10","2025-10-23","2023-06-26","Telethon Kids Institute","OTHER",false,"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.","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.\n\nChronic 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.",[19],"Chronic Pain",[21,22,23],"Chronic pain","Post-operative pain","Paediatric surgery","OBSERVATIONAL",null,[],{"count":28,"type":29},5000,"ESTIMATED",[],[32],{"measure":33,"description":34,"timeFrame":35},"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.","12 months",[37],{"measure":38,"description":39,"timeFrame":35},"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.","ALL","16 Years",true,{"inclusion":44,"exclusion":45,"raw_text":46},[],[],"Inclusion Criteria:\n\nThe patient is undergoing a surgical procedure in either group elective (circumcision, hypospadias, orchidopexy, laparoscopic appendicectomy) or group emergency (laparoscopic appendicectomy, scrotal exploration)\n\nExclusion Criteria:\n\nThe parent and child have inadequate English language skills to understand the questionnaires\n\nChildren with significant\u002Fsevere developmental or cognitive delay based on a formal diagnosis.\n\nFamilies that are unable to complete the long-term follow up surveys.",[48],"CHILD",[50,66,80,93,107,121,135,148,162,175,190,202,209,221,234,246],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"contacts":57,"geoPoint":63},"University of California","NOT_YET_RECRUITING","San Francisco","California","94118","United States",[58,61],{"name":59,"role":60},"Jocelyn Wong","CONTACT",{"name":59,"role":62},"PRINCIPAL_INVESTIGATOR",{"lat":64,"lon":65},37.77493,-122.41942,{"facility":67,"status":52,"city":68,"state":69,"zip":70,"country":56,"contacts":71,"geoPoint":77},"Children's Hospital Colorado","Aurora","Colorado","80045",[72,76],{"name":73,"role":60,"phone":74,"email":75},"Melissa Brooks Peterson","+13035067817","melissa.brooks@childrenscolorado.org",{"name":73,"role":62},{"lat":78,"lon":79},39.72943,-104.83192,{"facility":81,"status":52,"city":82,"state":83,"zip":84,"country":56,"contacts":85,"geoPoint":90},"Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",[86,89],{"name":87,"role":60,"email":88},"Angelica Vargas","avargas@luriechildrens.org",{"name":87,"role":62},{"lat":91,"lon":92},41.85003,-87.65005,{"facility":94,"status":52,"city":95,"state":96,"zip":97,"country":56,"contacts":98,"geoPoint":104},"Children's Hospital of Michigan","Detroit","Michigan","48201",[99,103],{"name":100,"role":60,"phone":101,"email":102},"Angela Lindbloom","3137454049","alindblo@dmc.org",{"name":100,"role":62},{"lat":105,"lon":106},42.33143,-83.04575,{"facility":108,"status":52,"city":109,"state":110,"zip":111,"country":56,"contacts":112,"geoPoint":118},"Atrium Health-Wake Forest Baptist","Winston-Salem","North Carolina","27157",[113,117],{"name":114,"role":60,"phone":115,"email":116},"Thomas Templeton","+13367168791","ttemplet@wakehealth.edu",{"name":114,"role":62},{"lat":119,"lon":120},36.09986,-80.24422,{"facility":122,"status":52,"city":123,"state":124,"zip":125,"country":56,"contacts":126,"geoPoint":132},"Children's Medical Center (Dallas)","Dallas","Texas","75235",[127,131],{"name":128,"role":60,"phone":129,"email":130},"Arul Lingappan","+18325245242","arul.lingappan@utsouthwestern.edu",{"name":128,"role":62},{"lat":133,"lon":134},32.78306,-96.80667,{"facility":136,"status":52,"city":137,"state":124,"zip":138,"country":56,"contacts":139,"geoPoint":145},"Texas childrens hospital","Houston","77030",[140,144],{"name":141,"role":60,"phone":142,"email":143},"Adam Adler","17864177529","adamcadler@gmail.com",{"name":141,"role":62},{"lat":146,"lon":147},29.76328,-95.36327,{"facility":149,"status":52,"city":150,"state":151,"country":152,"contacts":153,"geoPoint":159},"Townsville University hospital","Douglas","Queensland","Australia",[154,158],{"name":155,"role":60,"phone":156,"email":157},"Priya Sreedharan","744331111","subhapriya.sreedharan@health.qld.gov.au",{"name":155,"role":62},{"lat":160,"lon":161},-19.32394,146.75234,{"facility":163,"status":52,"city":164,"state":165,"country":152,"contacts":166,"geoPoint":172},"Fiona Stanley Hospital","Perth","Western Australia",[167,171],{"name":168,"role":60,"phone":169,"email":170},"Neil Hauser","0438094395","neil.hauser@health.wa.gov.au",{"name":168,"role":62},{"lat":173,"lon":174},-31.95224,115.8614,{"facility":13,"status":8,"city":164,"state":165,"country":152,"contacts":176,"geoPoint":189},[177,181,185,187],{"name":178,"role":60,"phone":179,"email":180},"Natalie P Jowett","08 6456 4809","Natalie.Jowett@telethonkids.org.au",{"name":182,"role":60,"phone":183,"email":184},"Lliana Slevin","08 64564806","Lliana.slevin@telethonkids.org.au",{"name":186,"role":62},"Britta von Ungern-Sternberg, Professor",{"name":188,"role":62},"David Sommerfield, Associate",{"lat":173,"lon":174},{"facility":191,"status":52,"city":192,"country":152,"contacts":193,"geoPoint":199},"Flinders Medical Centre","Adelaide",[194,198],{"name":195,"role":60,"phone":196,"email":197},"Fiona Taverner","0418214442","fiona.taverner@sa.gov.au",{"name":195,"role":62},{"lat":200,"lon":201},-34.92866,138.59863,{"facility":203,"status":52,"city":192,"country":152,"contacts":204,"geoPoint":208},"Women 's and Children's Hospital",[205,207],{"name":195,"role":60,"phone":206,"email":197},"0418 214 442",{"name":195,"role":62},{"lat":200,"lon":201},{"facility":210,"status":52,"city":211,"country":152,"contacts":212,"geoPoint":218},"Royal Darwin Hospital","Tiwi",[213,217],{"name":214,"role":60,"phone":215,"email":216},"Edith Waugh","498002564","Edith.Waugh@nt.gov.au",{"name":214,"role":62},{"lat":219,"lon":220},-12.35876,130.878,{"facility":222,"status":52,"city":223,"country":224,"contacts":225,"geoPoint":231},"Hospital for Sick Children","Toronto","Canada",[226,230],{"name":227,"role":60,"phone":228,"email":229},"Jason Maynes","04168135934","jason.maynes@sickkids.ca",{"name":227,"role":62},{"lat":232,"lon":233},43.70643,-79.39864,{"facility":235,"status":52,"city":236,"country":224,"contacts":237,"geoPoint":243},"British Columbia Children's Hospital","Vancouver",[238,242],{"name":239,"role":60,"phone":240,"email":241},"Gillian Lauder","60587523455955","glauder@cw.bc.ca",{"name":239,"role":62},{"lat":244,"lon":245},49.24966,-123.11934,{"facility":247,"status":52,"city":248,"country":249,"contacts":250,"geoPoint":255},"Wellington Regional Hospital","Wellington","New Zealand",[251,254],{"name":252,"role":60,"email":253},"Dan Frei","daniel.frei@ccdhb.org.nz",{"name":252,"role":62},{"lat":256,"lon":257},-41.28664,174.77557,[],[260],{"name":261,"affiliation":13,"role":62},"Britta P von Ungern-Sternberg",[],[],{"nct_id":4,"conditions":265,"biomarkers":267},[19,266],"Post-Operative Pain",[],{"nct_id":4,"found":42,"summary":269,"prompt_version":279},{"design":270,"status":271,"heading":272,"summary":273,"follow_up":274,"word_count":275,"commitments":276,"compensation":277,"drugs_mentioned":278},"This is an observational study, meaning researchers will collect information without providing any specific interventions. It plans to enroll 5000 participants aged 0-16 years.","completed","Understanding Chronic Pain After Surgery in Children","This study, called POPSICLE, is looking at how often children experience long-lasting pain after common surgeries, what might cause it, and how it affects their lives. There are no specific treatments being tested; instead, researchers will gather information through questionnaires from children aged 0 to 16 who are having surgeries like appendectomies, circumcisions, or orchidopexies. The goal is to understand chronic post-surgical pain (CPSP) and its risk factors, including anxiety, pre-existing pain, and how pain is managed right after surgery. This information will help doctors improve care and reduce the chance of children developing chronic pain after an operation. The study aims to enroll 5000 participants.","Participants will be followed for 10-12 months after surgery, with the primary outcome measured at 12 months.",106,"You would complete questionnaires at six different times, starting before surgery and continuing up to 10-12 months after surgery. These questionnaires will assess pain and how you are functioning.","Not stated in the trial record.",[],"v2"]