| CTRI Number |
CTRI/2025/01/079361 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring Childrens Experiences with Pre-Surgery Fasting: A Comprehensive Multi-Hospital Study |
|
Scientific Title of Study
|
Investigating Childrens Experiences of Preoperative Fasting: A Multi-Centric Mixed-Model Cross-Sectional 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 Naveen Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. S N Medical College Jodhpur |
| Address |
Mathura Das Mathur Hospital, Emergency Medicine Department, Dr S N Medical College Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
09950230213 |
| Fax |
|
| Email |
drnaveenpaliwal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naveen Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. S N Medical College Jodhpur |
| Address |
Mathura Das Mathur Hospital, Emergency Medicine Department, Dr S N Medical College Jodhpur Rajasthan
RAJASTHAN
342001
India |
| Phone |
09950230213 |
| Fax |
|
| Email |
drnaveenpaliwal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Dr. S N Medical College Jodhpur |
| Address |
Mathura Das Mathur Hospital, Emergency Medicine Department, Dr S N Medical College Jodhpur Rajasthan
RAJASTHAN
342001
India |
| Phone |
09950230213 |
| Fax |
|
| Email |
drnaveenpaliwal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sampurnanand Medical College Residency road, Sector-D, Shastri Nagar, Jodhpur, Rajasthan, India 342003 |
|
|
Primary Sponsor
|
| Name |
Dr. Sampurnanand Medical College Jodhpur |
| Address |
Residency road, Setor-D, Shastri Nagar, Jodhpur, Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Bihani |
AIIMS Bhubaneshwar |
Department of anaesthesia, operation theatre complex, third floor, IPD building
Khordha
ORISSA |
9694490440
drpooja.bihani@gmail.com |
| Dr Rishabh Jaju |
AIIMS Deoghar |
Department of anaesthesiology, operation theatre complex, third floor, Ipd building
Deoghar
JHARKHAND |
7742454477
rishabh.cares@gmail.com |
| Dr Mridul Dhar |
AIIMS Rishikesh |
Department of anaesthesiology, operation theatre complex, third floor, IPD building
Dehradun
UTTARANCHAL |
971777833374
mriduldhar87@gmail.com |
| Dr Divya Gupta |
Himalayan Institute of Medical Sciences |
Department of Anaesthesiology, Operation theatre complex, IOD building
Dehradun
UTTARANCHAL |
9456570288
dr_divyagupta@rediffmail.com |
| Dr Neelam Dogra |
SMS Medical College |
department of anaesthesia, main operation theatre complex
Jaipur
RAJASTHAN |
9928709289
neelam_dogra24@yahoo.com |
| Dr Naveen Paliwal |
Umaid Hospital |
Umaid Hospital Hospital, Department of Anesthesiology, Operation theatre complex Dr S N Medical College Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
09950230213
drnaveenpaliwal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee Swami Rama Himalayan University |
Approved |
| IEC/Aiims/deo |
Approved |
| institutional ethical committee AIIMS Bhubaneswr |
Approved |
| institutional ethical committee AIIMS Rishikesh |
Approved |
| Institutional Ethics Committee Dr.Sampurnanand Medical College |
Approved |
| office of the ethics committee, S. M. S. Medical College and Attached Hospitals, Jaipur |
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 |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
All children with American Society of Anaesthesiology- Physical Status Grade I or II of either sex, aged between 7 year and 14yrs, and undergoing elective surgeries under general anaesthesia less than 120 minutes |
|
| ExclusionCriteria |
| Details |
1. Refusal of parental consent
2. Patients undergoing emergency surgery
3. Patients with increased risk of aspiration eg. patients with full stomach, patients with trache-esophageal fistula, patients with impaired consciousness, patients with swallowing disorders.
4. History of prematurity, seizures, syndromic babies and congenital heart disease
5. History of recent upper respiratory tract infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the experience of fasting durations among pediatric patients scheduled for elective surgery |
Before their operation to participate in a structured interview |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the actual fasting duration for clear liquid and solid meal
2. To evaluate the correlation between the fasting duration for clear liquid and thirst score using 10 points Visual Analogue Scale
3. To evaluate the correlation between the fasting duration for solid meal and hunger score using 10 points Visual Analogue Scale
4. To evaluate the correlation between the fasting duration for clear liquid and parental satisfaction using 5-point Likert scale
5. To explore the reasons for non-compliance with recommended fasting guidelines
|
Before their operation |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
28/01/2025 |
| 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="0"
Months="3"
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
|
Despite recommendations fasting
duration are prolonged in many institutes. Paucity of literature on evaluation
of the experience of fasting durations among pediatric patients scheduled for
elective surgery. Therefore, the study is designed to evaluate the experience
of fasting durations among pediatric patients and parents scheduled for elective
surgery and to investigate the reasons for non-compliance with these guidelines
despite the evidence. |