| CTRI Number |
CTRI/2021/08/035676 [Registered on: 16/08/2021] Trial Registered Prospectively |
| Last Modified On: |
16/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPARISON OF TWO ICU PAIN SCALES
|
|
Scientific Title of Study
|
COMPARATIVE ASSESSMENT OF PAIN IN
PATIENTS ADMITTED IN INTENSIVE CARE UNIT USING CRITICAL CARE PAIN OBSERVATION TOOL
AND BEHAVIORAL PAIN SCALE
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Azeem V P |
| Designation |
Junior Resident |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE JNMCH AMU ALIGARH UP INDIA 202002 |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE,JNMCH, AMU,A DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JNMCH,AMU,ALIGARH,UTTAR PRADESH, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7457000355 |
| Fax |
|
| Email |
azeemezi10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Moied Ahmed |
| Designation |
Professor |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY& CRITICAL CARE,JNMCH, AMU,ALIGARH,U.P, INDIA, 202002 |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE,JNMCH, AMU,ALIGARH,UTTAR PRADESH, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JNMCH,AMU,ALIGARH,UTTAR PRADESH, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897454739 |
| Fax |
|
| Email |
syedmoiedahmed123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Moied Ahmed |
| Designation |
Professor |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY& CRITICAL CARE,JNMCH, AMU,ALIGARH,U.P, INDIA, 202002 |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE,JNMCH, AMU,ALIGARH,UTTAR PRADESH, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, JNMCH,AMU,ALIGARH,UTTAR PRADESH, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897454739 |
| Fax |
|
| Email |
syedmoiedahmed123@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE JNMCH AMU ALIGARH |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology And Critical Care JNMCH AMU ALIGARH UP INDIA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE JNMCH AMU ALIGARH UP INDIA |
| Type of Sponsor |
Government 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 |
| Azeem V P |
Jawaharlal Nehru Medical College Aligarh |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE JNMCH AMU ALIGARH UP INDIA 202002
Aligarh
UTTAR PRADESH |
7457000355
AZEEMEZI10@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are not able to self report pain
Patients whose expected length of stay in ICU >12 hours
Mechanically ventilated patients |
|
| ExclusionCriteria |
| Details |
Presence of residual effects of neuromuscular blocking agents
Conscious patients
Deep coma, deep sedation
Severe brain injury
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the relationship between the BPS and CPOT in assessing pain in ventilated patients in ICU |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of the intensity of pain during non invasive procedures using BPS and CPOT |
4 weeks , 8 weeks ,12 weeks , 16 weeks , 20 weeks |
| Comparison of specificity and sensitivity of pain assessment between BPS and CPOT scales |
20 weeks |
| Assessment of sensitivity when both techniques combined |
20 weeks |
| Relationship between physiological parameters with that of BPS and CPOT |
4 weeks ,8 weeks ,12 weeks , 16 weeks , 20 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
16/08/2021 |
| 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="0"
Months="8"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Title : COMPARATIVE ASSESMENT OF PAIN IN PATIENTS ADMITTED IN INTENSIVE CARE UNIT USING CRITICAL CARE PAIN OBSERVATION TOOL AND BEHAVIOURAL PAIN SCALE Hypothesis : We hypothesis that CPOT is more sensitive and accurate to assess pain compared to BPS in critically ill patients Materials and methods: This study will be conducted in the department of anaesthesiology and critical care , JNMCH ,AMU Aligarh over a period of 8 months after obtaining clearance from ethical committee and board of studies Study design : Prospective , observational study Sample size 150
|