A longitudinal study looking at the prevalence, risk factors, and consequences of persistent post-surgical pain in children. (POPSICLE)
A postoperative pain study in children – a longitudinal evaluation. (POPSICLE)
The Kids Research Institute Australia
5,000 participants
Jun 26, 2023
Observational
Conditions
Summary
Chronic pain in children is a real and significant problem, affecting up to 1/3 of children and adolescents worldwide. The impacts of chronic pain can be profound- negatively affecting children’s physical, emotional and social health, and education. The health, social and economic consequences of children developing chronic pain extend to their family, the health service and wider society. Interventions to prevent or reduce chronic pain are crucial as adolescents with chronic pain are more likely to be depressed or anxious, more likely to feel helplessness and have reduced autonomy compared to healthy children. One area requiring further study is the progression of acute post-surgical pain to chronic pain. One in 20 Australian children undergo surgery every year, with Perth Children’s Hospital alone performing almost 18000 procedures annually. While most children make a full recovery after surgery, some develop chronic postoperative pain. A review of four studies (>600 children) across major surgeries reported 20% had chronic post-surgical pain at 12 months. The PCH complex pain service sees around twenty patients annually with significant dysfunction and pain following surgery. Developing chronic pain post-surgery has a distressing impact on these children and their families and significantly impacts quality of life and development. Biological factors and tissue trauma cannot fully explain chronic pain development. Risk factors associated with the development of postoperative chronic pain include pre-existing anxiety level of the child and the child’s ability to cope with pain. POPSICLE aims to understand how psychological, social and environmental factors may play a role in the development and maintenance of chronic pain in children. Over three years, we will follow children (0-15 yrs) undergoing common paediatric surgeries in a series of longitudinal prospective cohorts involving pre-operative and post-operative surveys of parents and patients. Initially, we will include planned procedures (orchidopexy, circumcision) and urgent procedures (appendicectomies, surgery for testicular torsion), before incorporating other common paediatric surgeries. This newly acquired knowledge will lead to the development of strategies that reduce poor pain outcomes in children. 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.
Eligibility
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Interventions
The study was designed to capture data over 10-12 months, across multiple domains as recommended by PedIMMPACT (Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) including pain intensity; physical functioning; emotional functioning; social functioning; pain interference and sleep. Measures were taken at standardised timepoints as detailed below. Children greater than 8 years of age will complete their own questionnaires, but for pragmatic reasons parent proxy questionnaires will be used for children under 8 years of age. Where appropriate shorter versions of the scales have been chosen predominantly because the shorter version measures what we want and reduces load on patients and parents. Measures will be taken at the following timepoints: • T0: baseline measures (before day of surgery if possible) • T1: Intra hospital and immediate post-operative period • T2: Monring of Day 2 • T3: 3 –4 weeks post-surgery • T4: 3-4 months post-surgery • T5: 10-12 months post-surgery Questionnaires will be completed by the families on the online REDCAP application. The estimated timeframes for completion of the questionnaires are as follows: T0; 30 minutes, T1; 5 minutes and T3/4/5 20 minutes. T0: Baseline measurements (before day of surgery if possible) Child (>8 years) • Verbal Number Rating scale (vNRS) 0-10 to assess pain at rest/movement and worse and average, and pain unpleasantness rating for 7 days prior to this admission • The Michigan Body Map (MBM) scale for acute pain • Pain Catastrophizing Scale-Children (PCS-C) • Functional Disability Index (FDI) in 2 weeks prior to admission • Revised Child Anxiety and Depression Scale (RCADS) -Short 25 question version • Is there pre-existing pain episodes (for 3 months or more) present: If Yes: • Average and worst pain vNRS (0-10) in the last 7 days • Ped Pain Screening Tool (PPST) • Leeds Assessment of Neuropathic signs and symptoms (LANSS) Corresponding parent measures: • Average Verbal Number Rating Scale (vNRS) NRS-Worst, NRS-Average, NRS-Movement, NRS-Rest in the last 12hrs • Paediatric Quality of life Inventory parent Report - PedsQL v4.0 • The Michigan Body Map (MBM) scale for acute pain • Medication use for pain, • Pain Catastrophizing Scale-Parent (PCS-P) • Generalised Anxiety Disorder (GAD-7) Is there pre-existing pain episodes (for 3 months or more) present: If Yes: • Frequency of pain • Average and worst pain vNRS (0-10) in the last 7 days • PROMIS Parent Proxy Bank v2.0 - Pain Interference • Michigan Body Map (MBM) Child (5-8 years, parent proxy used for most or all) • Faces pain scale (FPS) • Before this time, how much is pain a problem for you normally? (Faces scale– never/sometimes/almost always) Corresponding parent measures: • Average Verbal Number Rating Scale (vNRS) NRS-Worst, NRS-Average, NRS-Movement, NRS-Rest in the last 12hrs • The Michigan Body Map (MBM) scale • Paediatric Quality of life Inventory: parent Report (PedsQL v4.0) • Prior pain medication use • Pain Catastrophizing Scale-Parent (PCS-P) • Revised Child Anxiety and Depression Scale (RCADS) – Parent Proxy • Generalised Anxiety Disorder (GAD-7) Is there pre-existing pain episodes (for 3 months or more) present: If Yes: • Frequency of pain • Average and worst pain vNRS (0-10) in the last 7 days • PROMIS Parent Proxy Bank v2.0 - Pain Interference • Michigan Body Map (MBM) • Leeds Assessment of Neuropathic signs and symptoms (LANSS) T1: Intra hospital and immediate post-operative period (24-48 hours) Obtained from anaesthesia & surgical records: surgery type and duration, regional techniques, systemic opioids & ketamine use, premedication (midazolam/clonidine/anti-neuropathic), demographics, weight, ASA • Surgery specific factors or details • Acute pain score – highest recorded PACU & Ward (first 12hrs) • Opioid use post operatively (until 8am morning D2 post-surgery) T2: Morning of Day 2 • Pain score (worst/average) and pain unpleasantness rating on morning of day 2 • How stressful did you find theatre/surgery experience (5 Point scale) /or Parent proxy if <8yrs • Parent satisfaction with quality of pain management (10-point scale –inadequate to comfortable) T3: (3-4 weeks), T4: (3-4 months), T5: (10-12 months) Child (>8 years) • Verbal Number Rating Scale (vNRS) 0-10. Worst/ average Pain NRS-W, NRS-A • Pain unpleasantness rating (vNRS-U) - last 7 days • If pain present: • Leeds Assessment of Neuropathic signs and symptoms LANSS • The Michigan Body Map (MBM) scale Parent measures (if >8 years) • Pain Frequency • Verbal Number Rating Scale (vNRS) Average and worst pain Intensity NRS-A, NRS-W (last 7 days) • Paediatric Quality of life Inventory: parent Report (PedsQL v4.0) • Pain Medication use • Pain Healthcare use since discharge or last time point • Non-pain related healthcare use since discharge or previous time point (GP/ED/Admissions) Child 5-8 years • Faces pain scale (FPS) • Is pain a problem for you normally? (Faces scale– never/sometimes/almost always) Parent measures (if <8 years) Pain frequency and average pain intensity rating (last 7 days) • The Michigan Body Map (MBM) scale • Verbal Number Rating Scale • PedsQL Parent Report • Pain medication use • Pain Healthcare use since discharge or last time point • Non-pain healthcare use since discharge, or previous time point (GP/ED/Admissions) If pain present: • PROMIS Parent Proxy Bank v2.0 - Pain Interference • The Michigan Body Map (MBM) scale • Leeds Assessment of Neuropathic signs and symptoms (LANSS)
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ACTRN12623000517673