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NCT06354699RecruitingAccepts Healthy Volunteers

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

Telethon Kids Institute

Start Date

6/26/2023

Completion Date

7/1/2028

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.

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.

Eligibility Criteria

Age Range: No minimum to 16 years

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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Conditions

Chronic Pain

Locations

University of California

San Francisco, California 94118

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

Children's Hospital of Michigan

Detroit, Michigan 48201

United States

Atrium Health-Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

Children's Medical Center (Dallas)

Dallas, Texas 75235

United States

Texas childrens hospital

Houston, Texas 77030

United States

Townsville University hospital

Douglas, Queensland

Australia

Fiona Stanley Hospital

Perth, Western Australia

Australia

Telethon Kids Institute

Perth, Western Australia

Australia

Flinders Medical Centre

Adelaide,

Australia

Women 's and Children's Hospital

Adelaide,

Australia

Royal Darwin Hospital

Tiwi,

Australia

Hospital for Sick Children

Toronto,

Canada

British Columbia Children's Hospital

Vancouver,

Canada

Wellington Regional Hospital

Wellington,

New Zealand