| CTRI Number |
CTRI/2025/06/088352 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
SURVEY |
| Study Design |
Other |
|
Public Title of Study
|
Knowledge and attitude of anesthesiology resident doctors towards pain assessment in children |
|
Scientific Title of Study
|
A survey to evaluate the knowledge and attitude of anesthesiology resident doctors towards peri-operative pain assessment in children. |
| 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. Anju Bhalotra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Critical Care.
B. L. Taneja Block.
Maulana Azad Medical College.
Bahadur Shah Zafar Marg. New Delhi
New Delhi DELHI 110002 India |
| Phone |
9968604219 |
| Fax |
|
| Email |
drakgk@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Anju Bhalotra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anesthesiology & critical care.
B.L.Taneja Block.
Bahadur Shah Zafar Marg.
Maulana Azad Medical College.
DELHI 110002 India |
| Phone |
9968604219 |
| Fax |
|
| Email |
drakgk@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr. Anju Bhalotra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anesthesiology & Critical Care.
B.L.Taneja Block.
Maulana Azad Medical College.
Bahadur Shah Zafar Marg.
DELHI 110002 India |
| Phone |
9968604219 |
| Fax |
|
| Email |
drakgk@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College.
Bahadur Shah Zafar Marg.
New Delhi- 110002. India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg.
New Delhi- 110002.
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 |
| Dr Anju Bhalotra |
Maulana Azad Medical College |
B.L. Taneja Block.
Anaesthes Department
Bahadur Shah Zafar Marg. New Delhi DELHI |
9968604219
drakgk@yahoo.co.in |
|
|
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 |
| Healthy Human Volunteers |
Attitude and knowledge towards pediatric pain management |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
24.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Anesthesiology
resident doctors with 6 months to 6 years of experience in anesthesia practicing pediatric anesthesia. |
|
| ExclusionCriteria |
| Details |
Anesthesiology residents with experience less than 6 months in practicing paediatric anesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| awareness about any pain assessment tool in children |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| creation of awareness in resident doctors of anesthesiology regarding pediatric pain assessment |
1 year |
|
|
Target Sample Size
|
Total Sample Size="270" Sample Size from India="270"
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)
|
20/06/2025 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drakgk@yahoo.co.in].
- For how long will this data be available start date provided 03-02-2025 and end date provided 03-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Adequate paediatric pain management is now universally considered an ethical obligation, its study as a necessity, rather than a luxury. The assessment and treatment of paediatric pain remain a challenge and untreated pain can have long-term negative consequences. The present study aims at identifying the current knowledge, attitude and practices among resident doctors towards perioperative paediatric pain assessment in the hospitals of Delhi. With the approval of the Institutional Ethics Committee, a cross-sectional survey will be conducted using a structured and pre- validated questionnaire |