| CTRI Number |
CTRI/2026/03/106675 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of three pain assessment methods for detecting pain in mechanically ventilated patients after surgery in the intensive care unit. |
|
Scientific Title of Study
|
Comparison of Critical Care Pain Observation Tool, Behavioral Pain Scale and Non-verbal Pain Scale for Pain Assessment in Mechanically Ventilated Post Surgical ICU Patients : A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raj kumar A |
| Designation |
DrNB Critical Care Medicine resident |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
4th Floor D block
Department of Critical care medicine
Sir Ganga Ram Hospital
Central DELHI 110060 India |
| Phone |
9841650097 |
| Fax |
|
| Email |
raj050496@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Debashis Dhar |
| Designation |
Vice Chairman and Senior Consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
4th floor D block
Vice chairman office
Department of Critical care medicine
Sir Ganga Ram Hospital
Central DELHI 110060 India |
| Phone |
9811231261 |
| Fax |
|
| Email |
ddhar2001@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Raj kumar A |
| Designation |
DrNB Critical Care Medicine resident |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
4th Floor D block
Department of Critical care medicine
Sir Ganga Ram Hospital
Central DELHI 110060 India |
| Phone |
9841650097 |
| Fax |
|
| Email |
raj050496@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Sir Ganga Ram Marg
Old Rajinder Nagar
New Delhi-110060 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Raj kumar A |
Sir Ganga Ram Hospital |
4th floor D block
Department of Critical Care Medicine
Sir Ganga Ram Hospital
Sir Ganga Ram Marg
Old Rajinder Nagar
Central DELHI |
9841650097
raj050496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sir Ganga Ram Hospital Ethics Comittee |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Post operative patients admitted to ICU and mechanically ventilated for 24 hrs.
2.Adult patients both males and female 18 years of age or more.
3.Hemodynamically stable at assessment time
4.Ramsay sedation scale 4 and 5
|
|
| ExclusionCriteria |
| Details |
1. Patients with quadriplegia, use of neuromuscular blocking agents, presence of peripheral neuropathy
2.Morbidly obese (BMI greater than 40), pregnancy, left ventricular ejection fraction less than 25%.
3.Patients with ongoing treatment for chronic pain, pre-existing psychiatric or neurological issues.
4.Family members of eligible patients not willing to participate in the study.
5.Ramsay sedation scale greater than 5.
6.Patients given breakthrough analgesia or sedation during the assessment.
7.Patients receiving drugs likely to blunt or distort heart rate and blood pressure responses to nociceptive stimuli |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scores assessed by various behavioral pain tools (CPOT, BPS and NVPS) in response to a nociceptive procedure as determined by changes in physiological parameter (HR/MAP) |
Baseline rest, during nociceptive procedures, and 20 minutes after completion of the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in individual behavioral component scores within CPOT, BPS & NVPS in response to nociceptive procedures |
Baseline rest, during nociceptive procedures & 20 minutes post-procedure. |
|
|
Target Sample Size
|
Total Sample Size="106" Sample Size from India="106"
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)
|
28/03/2026 |
| 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) |
Not Yet Recruiting |
|
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
|
Pain assessment in
critically ill patients, particularly those who are mechanically ventilated and
unable to self-report, remains a significant challenge in intensive care
practice. Effective pain management is central to improving patient comfort,
reducing physiological stress, minimizing complications, and enhancing
recovery. However, conventional self-reporting methods are not feasible in
sedated or intubated patients, making reliance on observational and behavioral
assessment tools essential. Several behavioral pain
assessment scales have been developed and validated internationally, including
the Critical-Care Pain Observation Tool (CPOT), Behavioral Pain Scale (BPS),
and Non-Verbal Pain Scale (NVPS). Each of these tools measures pain through a
combination of behavioral indicators and, in some cases, physiological
parameters. Although they have been used in diverse ICU populations, their
comparative performance in post-surgical mechanically ventilated patients
within the Indian context has not been studied to the best of our knowledge. This prospective observational study will
compare three behavioral pain assessment tools CPOT, BPS and NVPS in 106
mechanically ventilated post-surgical ICU patients. Pain assessments will be
conducted at baseline and during standard nociceptive ICU procedures, including
repositioning, endotracheal suctioning, and wound/drain management.
Physiological indicators, specifically a greater or equal to 20 percent increase in heart rate or mean
arterial pressure from baseline, will be used as a gold standard to evaluate
the diagnostic accuracy of each tool. The primary objective is to compare the reliability, sensitivity, and
specificity of CPOT, BPS and NVPS against physiological responses. The
secondary objective is to analyze the internal consistency and component-level
responsiveness of each scale to determine the most predictive behavioral
indicators of pain. By addressing this gap, the
study seeks to identify the most reliable and valid behavioral pain assessment
tool for use in post-surgical ICU patients. The findings are expected to
contribute to standardized pain assessment protocols, improve clinical decision-making
and enhance the overall quality of critical care delivery in the Indian
healthcare setting. |