Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000517673
Ethics application status
Approved
Date submitted
21/03/2023
Date registered
19/05/2023
Date last updated
28/01/2024
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A longitudinal study looking at the prevalence, risk factors, and consequences of persistent post-surgical pain in children. (POPSICLE)
Scientific title
A postoperative pain study in children – a longitudinal evaluation. (POPSICLE)
Secondary ID [1] 308054 0
None
Universal Trial Number (UTN)
None
Trial acronym
POPSICLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children undergoing elective hypospadias repair surgery under general anaesthesia. 327748 0
Children undergoing elective laparoscopic appendicectomy surgery under general anaesthesia. 329602 0
Children undergoing elective orchiopexy surgery under general anaesthesia. 329603 0
Children undergoing elective circumcision surgery under general anaesthesia. 329604 0
Children undergoing emergency laparoscopic appendicectomy surgery under general anaesthesia. 329605 0
Children undergoing emergency scrotal exploration surgery under general anaesthesia. 329606 0
Condition category
Condition code
Anaesthesiology 324819 324819 0 0
Pain management
Surgery 324820 324820 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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)
Intervention code [1] 324504 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334212 0
The prevalence of chronic post-surgical pain (CPSP) in paediatric patients at 10-12 months as defined by the ICD11 criteria through the following assessments: parent verbal number rating scale, child verbal number rating scale or facial pain scale for pain in the same areas as surgery based on the parent and child Michigan Body Map. (Composite outcome)
Timepoint [1] 334212 0
T0: baseline measures (before day of surgery if possible) or up to 72 hours post-operatively
T1: Immediately post-operatively/ in PACU
T2: morning of Day 2
T3: 3 to 4 weeks post-surgery
T4: 3 to 4 months post-surgery
T5: 10 to 12 months post-surgery
Secondary outcome [1] 419853 0
Assess the impact of biopsychosocial risk factors, including baseline parent anxiety, child anxiety (T0), pre-existing pain (T0), peri-operative pain (T2), acute post-operative management and surgical factors, on patient's return to normal function normal function (T3-T5) as measured by Leeds Assessment of Neuropathic signs and symptoms (LANSS), parental vNRS, child vNRS or facial pain scale, Michigan Body Map (MBM), Functional Disability Index (FDI), Paediatric Quality of Life (PedsQL) and PROMIS Pain Interference. (Composite outcome.)
Timepoint [1] 419853 0
T0: baseline measures (before day of surgery if possible) or up to 72 hours post-operatively
T1: Immediately post-operatively/ in PACU
T2: morning of Day 2
T3: 3 to 4 weeks post-surgery
T4: 3 to 4 months post-surgery
T5: 10 to 12 months post-surgery

Eligibility
Key inclusion criteria
Children aged 0 to 16 years undergoing a surgical procedure in either group elective (laparoscopic appendicectomy, circumcision, hypospadias repair or orchidopexy surgeries) or group emergency (laparoscopic appendicectomy or scrotal exploration surgeries)
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The response variable (pain score) will be modelled as a clustered longitudinal linear model, with sites as clusters. Appropriate variance and correlation structures will be included. All statistical analysis will be conducted in the R statistical environment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
26/06/2023
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
5000
Accrual to date
66
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 23582 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 23584 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [3] 24309 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 24310 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 39005 0
5006 - North Adelaide
Recruitment postcode(s) [2] 39864 0
5042 - Bedford Park
Recruitment postcode(s) [3] 39003 0
6009 - Nedlands
Recruitment postcode(s) [4] 39863 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 25021 0
Canada
State/province [1] 25021 0
Country [2] 25335 0
United States of America
State/province [2] 25335 0
Country [3] 26119 0
New Zealand
State/province [3] 26119 0
Country [4] 26120 0
United Kingdom
State/province [4] 26120 0
Country [5] 26121 0
Italy
State/province [5] 26121 0

Funding & Sponsors
Funding source category [1] 312309 0
Hospital
Name [1] 312309 0
Perth Children's Hospital
Country [1] 312309 0
Australia
Funding source category [2] 312311 0
Government body
Name [2] 312311 0
NHMRC
Country [2] 312311 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Telethon Kids Institute
Northern Entrance
Perth Children’s Hospital
15 Hospital Avenue
NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 313864 0
None
Name [1] 313864 0
Address [1] 313864 0
Country [1] 313864 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311678 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 311678 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
Ethics committee country [1] 311678 0
Australia
Date submitted for ethics approval [1] 311678 0
21/06/2022
Approval date [1] 311678 0
27/09/2022
Ethics approval number [1] 311678 0
RGS0000003993

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121966 0
Prof Britta von Ungern-Sternberg
Address 121966 0
Department of Anaesthesia and Pain Medicine
Perth Children's Hospital
15 Hospital Ave
Nedlands
WA 6009
Country 121966 0
Australia
Phone 121966 0
+61 864564805
Fax 121966 0
None
Email 121966 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for public queries
Name 121967 0
Prof Britta von Ungern-Sternberg
Address 121967 0
Department of Anaesthesia and Pain Medicine
Perth Children's Hospital
15 Hospital Ave
Nedlands
WA 6009
Country 121967 0
Australia
Phone 121967 0
+61 864564805
Fax 121967 0
None
Email 121967 0
Britta.Regli-VonUngern@health.wa.gov.au
Contact person for scientific queries
Name 121968 0
Prof Britta von Ungern-Sternberg
Address 121968 0
Department of Anaesthesia and Pain Medicine
Perth Children's Hospital
15 Hospital Ave
Nedlands
WA 6009
Country 121968 0
Australia
Phone 121968 0
+61 864564805
Fax 121968 0
None
Email 121968 0
Britta.Regli-VonUngern@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
None


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.