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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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