| CTRI Number |
CTRI/2025/03/081819 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Investigating Optimal Approaches to Postoperative Nil by Mouth |
|
Scientific Title of Study
|
Investigating Optimal Approaches to Postoperative Nil by Mouth: A Preliminary Exploratory Study in Paediatric Patients
Protocol
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMRITA RATH |
| Designation |
Associate professor |
| Affiliation |
Institute of medical sciences, BHU |
| Address |
3rd floor, Department of Anaesthesiology,
Institute of medical sciences, Banaras Hindu university lanka Varanasi UTTAR PRADESH 221005 India |
| Phone |
07379140545 |
| Fax |
|
| Email |
amritar@bhu.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Amrita Rath |
| Designation |
Associate Professor |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
3rd floor, Department of Anaesthesiology
Institute of medical sciences
Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
07379140545 |
| Fax |
|
| Email |
amritar@bhu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Amrita Rath |
| Designation |
Associate Professor |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
3rd floor, Department of Anaesthesiology
Institute of medical sciences
Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
07379140545 |
| Fax |
|
| Email |
amritar@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University,
Varanasi, Uttar Pradesh, India-221005 |
|
|
Primary Sponsor
|
| Name |
Institute of medical sciences, BHU |
| Address |
Banaras Hindu University, Lanka, varanasi, 221005 |
| 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 Vrushali Ponde |
Surya Children Hospital |
Department of Anaesthesiology Mumbai MAHARASHTRA |
9819886502
vrushaliponde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute ethical committee, institute of medical sciences, BHU |
Approved |
| medical ethics committee-clinical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 to 5 years undergoing daycare such as hernia, Opexy, circumcision Cystoscopy and Urethral Dilatation and Removal of moles, cysts, or other benign skin lesions
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria: Surgeries with hospital stay,cavity invading surgeries, children prone to nausea and vomiting, and cases where parental consent is refused.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of POV in the immediate post operative period |
Incidence of POV in the immediate post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.time to first oral sip as per stewards score and time to first oral semisolid intake on demand
2. Pain score at 2, 4, 8, 12 and 24 hours using FLACC scale
3. Time to discharge
4. Parent satisfaction scale
5. Complications, if any |
Pain score at 2, 4, 8, 12 and 24 hours using FLACC scale
|
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
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)
|
12/03/2025 |
| 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="6" 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
|
Introduction: The literature extensively discusses preoperative fasting guidelines for pediatric patients(1). In contrast, postoperative Nil by Mouth (NBM) strategies in pediatric patients have received limited attention, baring a few articles (2,3). Practices regarding postoperative NBM vary, influenced by individual preferences and the nature of the surgical procedure, impacting patient safety and recovery (2,3). Major abdominal surgeries may necessitate a longer NBM period for the gastrointestinal tract to recover, while superficial surgeries, like circumcisions and hernia repairs, may have shorter NBM periods due to their minimal impact on the gastrointestinal system. The timing of introducing semisolid foods post-surgery varies among healthcare professionals, influenced by factors such as surgery type, patient condition, and institutional guidelines. The European Society of Anaesthesiology recommends resuming liquid intake within 3 hours post-surgery in adults. Allowing normal food intake on the day of surgery in adults has shown positive effects, including a shorter time to bowel function resumption, reduced hospital stay, and fewer postoperative complications. Postoperative fasting is crucial in pediatric daycare procedures, impacting discharge timing significantly. To address this, we are initiating a prospective randomized controlled trial in daycare pediatric surgeries. Our goal is to assess the feasibility of introducing a regimen involving clear fluids initially, followed by a transition to a soft diet based on the child’s recovery score, providing insights into determining the optimal postoperative Nil By Mouth (NBM) period for pediatric patients undergoing daycare surgeries. |