| CTRI Number |
CTRI/2020/08/027309 [Registered on: 21/08/2020] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe whether 2 pain scales, which are Critical Care Pain Observation Tool(CPOT) and Behavioural Pain Scale (BPS) is accurate in assessing pain in Intensive Care Unit(ICU) patients on ventilator |
|
Scientific Title of Study
|
Accuracy of Critical Care Pain Observation Tool and Behavioral Pain Scale to Assess Pain in Mechanically Ventilated Critically Ill Patients: A Prospective, Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1256-2725 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Derlin Thomas |
| Designation |
Assistant Professor |
| Affiliation |
Amala Institute of Medical Sciences,Thrissur,Kerala |
| Address |
Department of Anesthesiology,
Amala Institute of Medical Sciences,
Thrissur,Kerala
Thrissur
KERALA
680555
India |
| Phone |
9447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Edwin J George |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences, Thrissur,Kerala |
| Address |
Department of Medicine,
Amala Institute of Medical Sciences,
Thrissur,Kerala
Thrissur
KERALA
680555
India |
| Phone |
9895419147 |
| Fax |
|
| Email |
dredwinofficial@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Edwin J George |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences, Thrissur,Kerala |
| Address |
Department of Medicine,
Amala Institute of Medical Sciences,
Thrissur,Kerala
Thrissur
KERALA
680555
India |
| Phone |
9895419147 |
| Fax |
|
| Email |
dredwinofficial@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences,Amala nagar Thrissur, Kerala-680555 |
|
|
Primary Sponsor
|
| Name |
Amala Institute of Medical Sciences |
| Address |
Amala Institute of Medical Sciences, Amalanagar,
Thrissur, Kerala |
| Type of Sponsor |
Private medical college |
|
|
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 Derlin Thomas |
Amala Institute of Medical Sciences |
Sicu,1st Floor, Chavara Block;
Micu,6th floor,St Marys Block;
Ssicu,2nd floor,Sacred Heart Block;
Thrissur
KERALA |
9447768944
derlin.t@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amala Ethics Committee |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
who were endotracheally intubated and required mechanical ventilation in ICU |
|
| ExclusionCriteria |
| Details |
Patients were excluded if
1. if they were quadriplegic
2. receiving neuromuscular blocking medications
3. had a peripheral neuropathy,
4. pregnancy, and morbid obesity
5. received medical treatment for chronic pain
6. had a left ventricular ejection fraction <0.25
7. had pre-existing psychiatric or neurological problems
8. had a dependence on alcohol or drugs
9. had complications after surgery (e.g., haemorrhage and delirium).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare CPOT and BPS in unconscious critically ill mechanically ventilated patients and to determine the most relevant parameters for evaluation of pain in those patients. |
At the completion of the study ie.at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare both pain scales with NVPS (Non Verbal Pain Scale) in these patients and to identify the best combination of scales for evaluating pain. |
At the completion of the study ie.at 6 months |
| To compare the accuracy of CPOT, BPS and NVPS with physiological indicators such as blood pressure and heart rate for pain assessment in critically ill patient. |
At the completion of the study ie.at 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pain management in critically ill patients is highly underestimated, even though it seems to be the patient’s worst memory in ICU, even after 5 years of discharge. In unconscious patients, 2 scales have been proposed to assess pain in ICU patients: Critical Care Pain Observation Tool (CPOT) and Behavioural Pain Scale(BPS). However the potential superiority of each of them for assessment of pain in mechanically ventilated patients is not well established. Hence, we designed this study to evaluate the accuracy between CPOT and BPS scales in assessing pain in mechanically ventilated critically ill patients.After meeting the inclusion and exclusion criteria, a total of 50 patients will be recruited for the study. The patients will receive sedation as per institutional protocol. Sedation will be assessed using Ramsay Scale. After recruitment all patients will be assessed for pain using CPOT, BPS and NVPS (non verbal pain scale), along with physiological indicators of pain ie. heart rate and arterial blood pressure at 2 time points, one in the morning and one at night. At each of these time points, pain will be assessed at rest as well as at 2 painful nursing procedures ie. tracheal suctioning and body positioning. |