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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  
nil 
 
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  
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 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  
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 
 
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.

 
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