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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
|
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. |