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CTRI Number  CTRI/2025/03/082642 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   EFFECTIVENESS OF PAIN RELIEF METHODS IN CHILDREN UNDERGOING LIVER TRANSPLANTATION 
Scientific Title of Study   PERIOPERATIVE ANALGESIC STRATEGIES IN PAEDIATRIC LIVER TRANSPLANT RECIPIENTS 
Trial Acronym  PAPs 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Susan Paulin 
Designation  Consultant 
Affiliation  Dr Rela Institute And Medical Centre 
Address  A5 Olympia grande apartments, Pallavaram, Chennai

Kancheepuram
TAMIL NADU
600043
India 
Phone  9994519890  
Fax    
Email  susanvercetti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Susan Paulin 
Designation  Consultant 
Affiliation  Dr Rela Institute And Medical Centre 
Address  A5 Olympia grande apartments, Pallavaram, Chennai


TAMIL NADU
600043
India 
Phone  9994519890  
Fax    
Email  susanvercetti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Susan Paulin 
Designation  Consultant 
Affiliation  Dr Rela Institute And Medical Centre 
Address  A5 Olympia grande apartments, Pallavaram, Chennai


TAMIL NADU
600043
India 
Phone  9994519890  
Fax    
Email  susanvercetti@gmail.com  
 
Source of Monetary or Material Support  
Dr. Rela Institute and medical centre 
 
Primary Sponsor  
Name  Dr. Rela institute and medical centre 
Address  ICU Office third floor, Dr. Rela Institute and Medical Centre, Chrompet, Chennai  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SUSAN PAULIN  Dr. Rela Institute and medical centre  Icu third floor, Dr Rela institute and medical centre, Chrompet, Chennai
Kancheepuram
TAMIL NADU 		 9994519890

susanvercetti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K743||Primary biliary cirrhosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All paediatric liver transplant recipients undergoing liver transplantation 
 
ExclusionCriteria 
Details  Patients not willing for participation
Multiorgan transplantation
Re-exploration on Postoperative day 3 and beyond
Re-intubation on postoperative day 3 and beyond  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the requirement of perioperative opioids in paediatric liver transplant recipients  Postoperative Day 0 to day 3 after liver transplant surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the need for the first rescue analgesic in the postoperative period  In the first 3 days following liver transplantation 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   09/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [scarf.69-splice@icloud.com].

  6. For how long will this data be available start date provided 01-04-2025 and end date provided 01-01-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Pain score will be assessed using the following age appropriate scales
Assessment will be done by independent assessors using dedicated scores. 
Peak pain score, total dosage of dexmedetomidine and opioids, average duration of analgesic requirement and details of rescue drugs with dosages used will be recorded during the study period. 
Complications such as hemodynamic changes requiring dose modifications or discontinuation of drugs, gastrointestinal symptoms such as nausea, vomiting, constipation, ileus will be recorded.
Vomiting will be recorded at 24, 48, 72 hours as per vomiting score (0: no nausea, no vomiting; 1: nausea alone; 2: one episode of emesis; and 3: two or more episodes of emesis)
 
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