FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/077530 [Registered on: 02/12/2024] Trial Registered Prospectively
Last Modified On: 29/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational 
Study Design  Other 
Public Title of Study   Does giving a sedative medicine (midazolam) to children with cancer help in improving the acceptance of anaesthesia mask before putting them to sleep? 
Scientific Title of Study   Oral midazolam premedication in paediatric oncology patients undergoing day care procedures- Does it improve mask acceptance? 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4559_Proctocol Version 1.1 dated 06/10/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayana Amin 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai- 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9820742327  
Fax    
Email  drnayana.amin@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nayana Amin 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai- 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9820742327  
Fax    
Email  drnayana.amin@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Prerana Dash 
Designation  Post graduate student 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai- 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  7369000339  
Fax    
Email  prerana.dash@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesia, Critical care and Pain, Second floor, Main building Tata Memorial Hospital, Parel, Mumbai-400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Dept of Anaesthesia, Critical care and Pain, Second floor, Main building Tata Memorial Hospital, Parel, Mumbai-400012 
Type of Sponsor  Research institution and hospital 
 
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 Nayana Amin  Tata Memorial Hospital  Department of Anesthesia Critical care and Pain, Second floor, Main Building Mumbai
Mumbai
MAHARASHTRA 
9820742327

drnayana.amin@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital_Institutional Ethics Committee II   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA  
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1)Age group-1 to 6years of either sex.
2)American society of anaesthesiology (ASA) 1, II & III
3)Informed consent by parents or guardians.
 
 
ExclusionCriteria 
Details  1)Patients with ASA grade IV or more.
2)children with anticipated difficult airway
3)Allergy history to midazolam
4)Unwilling patients.
5)Patients who receive IV induction agents
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To improve the mask acceptance score by use of oral midazolam as pre medication  Within 1 hour of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time of onset of sedation
2. Ease of separation from parents
3. Time to awaken
4. Time to discharge from recovery
 
All secondary outcomes will be assessed within 1 hour of intervention 
 
Target Sample Size   Total Sample Size="83"
Sample Size from India="83" 
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)   16/12/2024 
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 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  

Pre medication is given routinely as a part of standard anaesthesia care in paediatric patients undergoing major surgical procedures.This practice is not followed in paediatric patients undergoing short duration procedures as the parents are allowed to accompany the child into the operation theatre (OT). Even with the parents around, children fear and resist the process of mask induction. Often these children are posted for minor procedures multiple times and repeated exposure to this fear of mask can remain in the memory of the children leading to long term complications like enuresis, night terrors and other psychological disorders.Therefore, premedication of children is important for smooth induction of anaesthesia and recovery.

Oralmidazolam is the most widely used and accepted method of premedicating children. For ease of parental separation, we routinely giveoral midazolam premedication to all children undergoing major surgical procedures. Unlike procedures in major operation theatres where parents are not allowed to accompany the child into the operation theatre, parents are allowed inside the procedure rooms for day care procedures.Hence, premedication was avoided in children coming for day care procedures. Also, in high volume centres there is insufficient time between two procedures to give premedication to the children. However, despite the presence of parents children cry excessively and do not easily accept the mask for induction of anaesthesia.

The purpose of this study is to see if giving oral midazolam, helps to improve the mask acceptance during anaesthesia for short procedures (bone marrow biopsy/aspiration, csf analysis, intrathecal methotrexate injection) without causing any delay in between two procedures or any delay in discharge from the recovery.

 
Close