FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/06/054371 [Registered on: 23/06/2023] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Perfusion Index for measurement of post surgery pain 
Scientific Title of Study   Perfusion Index as a Measure of Postoperative Pain Assessment in Paediatric Patients undergoing Open Abdominal, Thoracic & Orthopaedic procedures  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nazia Tauheed 
Designation  IAPA fellow(SR) 
Affiliation   
Address  Postgraduate Institue of Child Health (PGICH) Sector - 30 Noida

Gautam Buddha Nagar
UTTAR PRADESH
201303
India 
Phone  7895330665  
Fax    
Email  naziatauheed15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nazia Tauheed 
Designation  IAPA fellow (SR) 
Affiliation   
Address  Postgraduate Institue of Child Health (PGICH) Sector - 30 Noida

Gautam Buddha Nagar
UTTAR PRADESH
201303
India 
Phone  7895330665  
Fax    
Email  naziatauheed15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nazia Tauheed 
Designation  IAPA fellow (SR) 
Affiliation   
Address  Postgraduate Institue of Child Health (PGICH) Sector - 30 Noida

Gautam Buddha Nagar
UTTAR PRADESH
201303
India 
Phone  7895330665  
Fax    
Email  naziatauheed15@gmail.com  
 
Source of Monetary or Material Support  
PGICH, Noida 
 
Primary Sponsor  
Name  Dr Nazia Tauheed 
Address  Postgraduate Institute of Child Health (PGICH) Sector-30, Noida  
Type of Sponsor  Other [self] 
 
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 
Dr Nazia Tauheed  Postgraduate Institute of Child Health (PGICH),  Department of Paediatric Anaesthesia 2nd Floor OT Complex Postgraduate Institute of Child Health (PGICH) Noida
Gautam Buddha Nagar
UTTAR PRADESH 
7895330665

naziatauheed15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGICH, Noida  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 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  10.00 Year(s)
Gender  Both 
Details  ASA I, II, III 
 
ExclusionCriteria 
Details  Developmental delay, Behavioural changes, Patients with cognitive deficiency or mental dysfunction, not giving consent, requirement of postoperative ventilatory support/ICU management 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Perfusion index correlation with postoperative pain measured by FLACC score  0, 30, 60, 90, 120 min of shifting to PACU  
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of Perfusion index with postoperative pain as measured by analgesic requirement   0, 10, 20, 30, 40 minutes of rescue analgesic requirement 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/07/2023 
Date of Study Completion (India) 12/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The perfusion index (PI) is an indirect non-invasive measurement of peripheral perfusion, calculated as a ratio of the pulsatile signals to the non-pulsatile signals obtained from pulse oximetry, derived from the amount of infrared (940nm) light absorbed. A decreased PI suggests vasoconstriction while a high value of PI would imply peripheral vasodilation. The sympathetic system being inherently related to pain, when it is activated by pain, an increased vasomotor tone and contraction of peripheral blood vessels would decrease PI. Similarly, when pain is relieved with adequate analgesia, PI would increase. Studies in adults have shown it as a promising tool in pain assessment. The objectivity of this tool as a potential pain assessor may be harnessed in the paediatric population as well. Literature search revealed that it has been used in paediatric postoperative pain assessment only in adenotonsillectomy patients.

The current study is being designed to assess the reliability of this objective marker in postoperative pain assessment in paediatric patients undergoing open abdominal, thoracic and orthopaedic procedures. The primary objective being to find a correlation between the severities of postoperative pain assessed by FLACC score and the corresponding postoperative perfusion index. 

 
Close