Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000058673
Ethics application status
Approved
Date submitted
9/01/2023
Date registered
17/01/2023
Date last updated
20/02/2024
Date data sharing statement initially provided
17/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Chronic pain following paediatric tonsillectomy
Scientific title
The prevalence of chronic post-surgical pain following paediatric tonsillectomy
Secondary ID [1] 308708 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Post-surgical pain
 328641 0
Condition category
Condition code
Anaesthesiology 325652 325652 0 0
Pain management
Surgery 325717 325717 0 0
Other surgery
Oral and Gastrointestinal 325718 325718 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Weeks
Description of intervention(s) / exposure
Structured interview via phone call to assess post surgical pain at 3 weeks and 12 weeks post tonsillectomy with or without adenoidectomy for any indication.
Each interview will take between 5-10 minutes and will be conducted by a member of the study team. The script and interview questions are set but a formal questionnaire will not be used.
If pain is found on the second phone call at 12 weeks, the participant will be assessed by pain physician which may be in person or via telehealth within 5 days.
If there is suspicions of chronic post surgical pain the Electronic Persistent Pain Outcome Collaboration (ePPOC) patient/parent questionnaire inclusive of the PedsQL questionnaire may be completed to guide further management.
A further detailed pain history will be undertaken by a pain physician to determine if the persistent pain is secondary to surgery and directed for further management.
Intervention code [1] 325171 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333495 0
Prevalence of chronic post surgical pain following paediatric tonsillectomy.

If there are suspicions of CPSP, the child and family will be referred to the RCH Chronic Pain Clinic where they will be seen by a Pain physician either in person or by telehealth along with an electronic paediatric pain outcome collaboration (ePPOC) questionnaire inclusive of the PedsQL questionnaire and a further detailed pain history will be undertaken to determine if the persistent pain is secondary to surgery and directed for further management.
These questionnaires will only be administered to those groups who report ongoing pain at the second phone call (12 weeks post tonsillectomy) following a referral to the RCH chronic pain clinic and review by a specialist paediatric pain physician.
Timepoint [1] 333495 0
3 weeks and 12 weeks (primary timepoint) post tonsillectomy
Secondary outcome [1] 417281 0
To determine the nature of chronic post surgical pain.

This outcome will be assessed using the Electronic Paediatric Pain Outcome Collaboration (ePPOC) questionnaire inclusive of the PedsQL questionnaire and assessment by pain physician at 12 weeks post tonsillectomy if there are suspicions of chronic post surgical pain
Timepoint [1] 417281 0
12 weeks post tonsillectomy
Secondary outcome [2] 417282 0
Explore the impact of chronic post surgical pain on function.

This outcome will be assessed using the Electronic Paediatric Pain Outcome Collaboration (ePPOC) questionnaire inclusive of the PedsQL questionnaire and assessment by pain physician at 12 weeks post tonsillectomy if there are suspicions of chronic post surgical pain.
Timepoint [2] 417282 0
12 weeks post tonisllectomy

Eligibility
Key inclusion criteria
• Is between the ages of 2 and 16 at enrolment
• Has undergone tonsillectomy with or without adenoidectomy for any indication.
• Been provided a verbal consent letter and/or has a legally acceptable representative capable of understanding the verbal consent document and providing consent on the participant’s behalf
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to be contacted for future assessments
• Non English Speaking Background and unable to complete a questionnaire

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A convenience sample of 150 (anticipating a dropout rate of around 10-15%) has been chosen.

If we determined 5% prevalence then the 95% confidence interval would be 1.5-11% which provides an acceptable degree of precision. If we found a 0% prevalence the upper bound of the 95% confidence interval would be 3.6%. If we determined a 10% prevalence then the 95% confidence interval would be 5-17% and we will then conduct a series of exploratory univariate analyses to assess if the pain is associated with any particular patient or surgical factor.

Following determination of prevalence for chronic post surgical pain, we will assess descriptive statistics of the population (age, gender, weight, BMI, surgical indication, surgical type) and then impact of chronic post surgical pain if present (ePPOC Questionnaire). All data will be expressed as a number, range, percent and mean and standard deviation as appropriate.

The nature of the pain will be described descriptively.

For the exploratory analysis where pain is present or not, numerical data between groups will be compared with a Student's t-test. Associations between categorical variables will be analysed using Pearson's chi squared tests. Logistical regressions will be performed to identify relationships between variables and chronic post surgical pain. A value p < 0.05 will be considered statically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/01/2023
Actual
19/01/2023
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
30/07/2024
Actual
Sample size
Target
150
Accrual to date
105
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23782 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 39229 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 312932 0
Hospital
Name [1] 312932 0
The Royal Children's Hospital Melbourne
Country [1] 312932 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital Melbourne
Address
50 Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 314616 0
Charities/Societies/Foundations
Name [1] 314616 0
Murdoch Children's Research Institute
Address [1] 314616 0
50 Flemington Road
Parkville VIC 3052
Country [1] 314616 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312204 0
The Royal Children's Hospital Melbourne
Ethics committee address [1] 312204 0
Ethics committee country [1] 312204 0
Australia
Date submitted for ethics approval [1] 312204 0
07/11/2022
Approval date [1] 312204 0
20/12/2022
Ethics approval number [1] 312204 0
88249

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

Contacts
Principal investigator
Name 123838 0
Dr Justin Hii
Address 123838 0
Royal Children's Hospital
50 Flemington Road, Parkville, Victoria 3052
Country 123838 0
Australia
Phone 123838 0
+61 393455233
Fax 123838 0
Email 123838 0
[email protected]
Contact person for public queries
Name 123839 0
Suzette Sheppard
Address 123839 0
Royal Children's Hospital
50 Flemington Road, Parkville, Victoria 3052
Country 123839 0
Australia
Phone 123839 0
+61 393454901
Fax 123839 0
Email 123839 0
[email protected]
Contact person for scientific queries
Name 123840 0
Justin Hii
Address 123840 0
Royal Children's Hospital
50 Flemington Road, Parkville, Victoria 3052
Country 123840 0
Australia
Phone 123840 0
+61 393455233
Fax 123840 0
Email 123840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
One year after publication of the primary outcome paper; no end date determined.
Available to whom?
Before data are shared, the study investigators will assess the scientific merit of the project requesting the data and ensure all ethical, regulatory and data transfer agreements are in order.
Available for what types of analyses?
Any purpose as long as the the scientific merit of the project is sound.
How or where can data be obtained?
By applying for access to the study principal investigators via email:
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17977Study protocol  [email protected]
17978Ethical approval  [email protected]
17979Informed consent form  [email protected]
17980Statistical analysis plan  [email protected]
17981Analytic code  [email protected]



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.