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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Britta P von Ungern-Sternberg | Telethon Kids Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Not yet recruiting | San Francisco | California | 94118 | United States |
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| Children's Hospital Colorado | Not yet recruiting | Aurora | Colorado | 80045 | United States |
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| Lurie Children's Hospital of Chicago | Not yet recruiting | Chicago | Illinois | 60611 | United States |
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| Children's Hospital of Michigan | Not yet recruiting | Detroit | Michigan | 48201 | United States |
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| Atrium Health-Wake Forest Baptist | Not yet recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Children's Medical Center (Dallas) | Not yet recruiting | Dallas | Texas | 75235 | United States |
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| Texas childrens hospital | Not yet recruiting | Houston | Texas | 77030 | United States |
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| Townsville University hospital | Not yet recruiting | Douglas | Queensland | Australia |
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| Fiona Stanley Hospital | Not yet recruiting | Perth | Western Australia | Australia |
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| Telethon Kids Institute | Recruiting | Perth | Western Australia | Australia |
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| Flinders Medical Centre | Not yet recruiting | Adelaide | Australia |
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| Women 's and Children's Hospital | Not yet recruiting | Adelaide | Australia |
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| Royal Darwin Hospital | Not yet recruiting | Tiwi | Australia |
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| Hospital for Sick Children | Not yet recruiting | Toronto | Canada |
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| British Columbia Children's Hospital | Not yet recruiting | Vancouver | Canada |
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| Wellington Regional Hospital | Not yet recruiting | Wellington | New Zealand |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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