CTRI

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CTRI Number

CTRI/2025/04/084685 [Registered on: 13/04/2025] Trial Registered Prospectively

Last Modified On:

12/03/2026

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

To study long term pain in children following surgery

Scientific Title of Study

POPSICLE "Post-Operative Pain Study in Children – a Longitudinal Evaluation"

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
ACTRN12623000517673	ANZCTR
NCT06354699	ClinicalTrials.gov

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Dootika Liddle
Designation	Professor
Affiliation	Christian Medical College & Hospital Ludhiana
Address	Department of Anaesthesia, Room Number 1237 Ludhiana PUNJAB 141008 India
Phone	9815484085
Fax
Email	dootika.liddle@cmcludhiana.in

Details of Contact Person
Scientific Query

Name	Dr Dootika Liddle
Designation	Professor
Affiliation	Christian Medical College & Hospital Ludhiana
Address	Department of Anaesthesia, Room Number 1237 Ludhiana PUNJAB 141008 India
Phone	9815484085
Fax
Email	dootika.liddle@cmcludhiana.in

Details of Contact Person
Public Query

Name	Dr Dhruva Ghosh
Designation	Professor
Affiliation	Christian Medical College & Hospital
Address	Department Of Paediatric Surgery Ludhiana PUNJAB 141008 India
Phone	9915198894
Fax
Email	dhruvghosh73@gmail.com

Source of Monetary or Material Support

Non Funded Study. The study in India is coordinated by: Department of Anesthesia alongwith the India HUb NIHR Health Research Unit on Global Surgery Christian Medical College Ludhiana, Punjab 141008 India

Primary Sponsor

Name	Telethon Kids Institute
Address	Perioperative Medicine Team, The Kids Research Institute Perth Children’s Hospital, 15 Hospital Avenue, Nedlands 08 6456 4806 and 0406 756 828 perioperativemedicineteam@telethonkids.org.au
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

Australia
Canada
India
Italy
New Zealand
United Kingdom
United States of America

Sites of Study

No of Sites = 11
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Bhuvaneswari Balasubramanian	All India institute of Medical Science	Department of Anesthesiology & Critical Care 1st Floor Nagpur MAHARASHTRA	9869074968 docbhuvaneswari@gmail.com
DrRakha Kundal	All India institute of Medical Science	Department of Anesthesia Room 132 first floor tower 4 Jammu JAMMU & KASHMIR	9910939123 raksha.kundal@aiimsjammu.edu.in
DrPraveen Talawar	All India institute of Medical Science, Rishikesh	Department of Anesthesiology Building 1, 6th floor Dehradun UTTARANCHAL	9845857787 praveenrt64@gmail.com
DrAshu Mathai	Believers Church Medical College Hospital Thiruvalla	Department of Anesthesia Pathanamthitta KERALA	9888500240 ashumathai@gmail.com
Dr Dootika Liddle	Christian Medical College Hospital Ludhiana	Department of Anesthesia, First Floor Room No. 1237 Ludhiana PUNJAB	9815484085 dootika.liddle@cmcludhiana.in
Dr Anita Shirley	Christian Medical College Vellore	Department of Anesthesia, 7th floor New Paul Brand Block Vellore TAMIL NADU	7358377164 anshirl@cmcvellore.ac.in
Dr Sanjeev Palta	Government Medical College	Department of Anesthesia Chandigarh CHANDIGARH	9646121523 sanjeev_palta@yahoo.com
Dr Shweta Sinha	Kasturba Medical College Manipal	Department of Anesthesia, 1st floor Balika block Udupi KARNATAKA	8879056117 shweta.sinha@manipal.edu
DrLovenish Bains	Maulana Azad Medical College	Department of General Surgery, Room no 201, BL Taneja Block New Delhi DELHI	9968604377 lovenishbains@gmail.com
DrPreethy Mathew	Post Graduate Institute of Medical Science	Department of Anesthesia and Intensive Care Chandigarh CHANDIGARH	9417800203 tjpreethy@gmail.com
DrShowkat Gurcoo	Sher-I-Kashmir Institute of Medical Sciences	Department of Anesthesia, first floor Srinagar JAMMU & KASHMIR	7006786265 gurcooshowkat@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 11
Name of Committee	Approval Status
Institutional Ethical Committee Sher-i-Kashmir Institute of Medical Sciences Srinagar (J&K)	Approved
Institutional Ethics Committee AIIMS Jammu	Approved
Institutional Ethics Committee AIIMS Nagpur	Submittted/Under Review
Institutional Ethics Committee AIIMS Rishikesh	Approved
Institutional Ethics Committee Believers Church Medical College Hospital, Thiruvalla	Submittted/Under Review
Institutional Ethics Committee CMC Ludhiana	Approved
Institutional Ethics Committee GMC Chandigarh	Submittted/Under Review
Institutional Ethics Committee Maulana Azad Medical College New Delhi	Submittted/Under Review
Institutional Ethics Committee PGI Chandigarh	Submittted/Under Review
Institutional Review Board CMC Vellore	Approved
Kasturba Medical College and hospital Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	1.00 Day(s)
Age To	16.00 Year(s)
Gender	Both
Details	1. The patient is undergoing a surgical procedure in either group elective (circumcision, hypospadias, orchidopexy, laparoscopic appendicectomy) or group emergency (laparoscopic appendicectomy, scrotal exploration) 2. Patient is aged between 1-16 years old.

ExclusionCriteria

Details

1. The parent and child have inadequate English or local language skills to understand the
questionnaires.

2.Children with significant/severe developmental or cognitive delay based on a formal diagnosis.

3.Families that are unable to complete the long-term follow up surveys.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Primary outcome will be the prevalence of chronic post-surgical pain (CPSP) in paediatric patients at 10-12 months as defined by the ICD11 criteria	One year follow up

Secondary Outcome

Outcome	TimePoints
Secondary endpoints will identify potential biopsychosocial risk factors contributing or maintaining CPSP, such as parent or child anxiety, pre-existing and perioperative pain, acute postoperative management, surgical factors, and to assess impacts on function one-year post surgery.	one year follow up

Target Sample Size

Total Sample Size="5000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

23/04/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

01/03/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The POPSICLE study is an international observational longitudinal prospective cohort study across

several paediatric centres to assess the prevalence, risk factors, and consequences of persistent

pain following common paediatric surgeries.

The POPSICLE study will be led by Perth Children’s Hospital.

The objective of this project is to assess the prevalence, risk factors, and consequences of

persistent pain following common paediatric surgeries through a series of longitudinal prospective

cohorts across several paediatric centres.

Primary outcome will be the prevalence of chronic post-surgical pain (CPSP) in paediatric patients

at 10-12 months as defined by the ICD11 criteria.

Secondary endpoints will identify potential biopsychosocial risk factors contributing or maintaining

CPSP, such as parent or child anxiety, pre-existing and perioperative pain, acute postoperative

management, surgical factors, and to assess impacts on function one-year post surgery.

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.

Baseline and demographic characteristics will be summarized by standard descriptive summaries

(e.g. means and standard deviations for continuous variables such as age and percentages for

categorical variables such as gender). The majority of research into development of chronic pain

post-surgery has been conducted in major elective surgeries, in particular spinal fusion surgeries

and is in the order of 20%. Other common paediatric surgeries including those selected for this

project are less well studied e.g. 1-2 % in orchidopexy and 9% in some day case hernias. There is

also wide variation in prevalence of CPSP across surgeries in adults. Thus, it is difficult to estimate

a sample size. The aim is to collect data for at least 5000 children between the participating sites to be able to assess the incidence of chronic pain. This will also allow the assessment of the impact of anxiety on postoperative pain. Statistical power calculations will be conducted following the recruitment of 5000 children to confirm if the sample size is adequate and recruitment will be

continued as required.