| 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
|
|
|
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
|
|
|
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. |