| CTRI Number |
CTRI/2025/08/093526 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of presence of parents with oral midazolam premedication for reducing preoperative anxiety in children undergoing elective surgery under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of parental presence with oral midazolam premedication for reducing preoperative anxiety in children undergoing elective surgery under general anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Averine Paulose |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS AND DR RML HOSPITAL NEW DELHI-110001 |
| Address |
Room no. 301 3rd floor Department of Anaesthesia ABVIMS and Dr RML hospital Central Delhi 110001 India
New Delhi
DELHI
110001
India |
| Phone |
9319414185 |
| Fax |
|
| Email |
averinep2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namita Arora |
| Designation |
Professor |
| Affiliation |
ABVIMS AND DR RML HOSPITAL NEW DELHI-110001 |
| Address |
Room no. 301 3rd floor Department of Anaesthesia ABVIMS AND DR RML HOSPITAL Central Delhi 110001 India
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namita Arora |
| Designation |
Professor |
| Affiliation |
ABVIMS AND DR RML HOSPITAL NEW DELHI-110001 |
| Address |
Room no. 301 3rd floor Department of Anaesthesia ABVIMS AND DR RML HOSPITAL Central Delhi 110001 India
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
drnamitaarora@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS AND Dr Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, 110001 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 Averine Paulose |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
Room no. 301 3rd floor Department of Anaesthesia ABVIMS and Dr RML Hospital Central Delhi 110001 India
North
DELHI |
9319414185
averinep2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and Dr. RML Hospital New Delhi |
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 |
Oral Midazolam |
Midazolam group (Group M), the child will be premedicated with 0.5 mg/kg oral midazolam mixed in honey. The parent will stay with the child in the preoperative room for 30 minutes duration and be separated when the child will be transferred to the operating room. |
| Comparator Agent |
Parental Presence |
In the Parental presence group (Group P) patients will be given plain honey orally. Parent will stay with the child and accompany him into the operating room till the induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiologists [ASA] physical status I and II patients.
2. AGE: 2-8yrs.
3. Elective surgical procedure
|
|
| ExclusionCriteria |
| Details |
1. Difficult airway
2. Mental or physical disabilities
3. Treatment with sedatives or anticonvulsant
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Anxiety score measured by Modified Yale preoperative anxiety scale Score (mYPAS)
|
mYPAS will be measured at 3 points :
1.just before shifting to OT 2.placing patient on OT table 3.On introduction of face mask during induction of anaesthesia.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Face Mask acceptance score by Mask acceptance scale (MAS)
Hemodynamic parameters (HR, SpO2) in both groups
|
1.Hemodynamic parameters will be recorded from the time of bringing the child in the preoperative room & then every 10 minutes till the time of putting the child on the operating table & placing the face mask for induction.
2.Face mask will be applied at the start of induction of anaesthesia. Mask acceptance score will be assessed by an independent observer using a 3 point Mask Acceptance Score |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
02/09/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Randomized Comparative
Study will be conducted in the Department of Anaesthesia, ABVIMS & Dr. Ram Manohar Lohia Hospital,
New Delhi- 110001 after the Institutional Ethics Committee Approval. Written
informed consent from patient’s parents will be taken. The study will include
patients, undergoing elective surgical procedures under General Anaesthesia. Sample size = 80 Primary objective is to compare parental
presence with oral midazolam premedication for reducing preoperative anxiety in
children undergoing elective surgery under general anaesthesia. Secondary objective is to compare the face mask acceptance score at the time of
induction between the two groups and compare the hemodynamic
parameters starting from preoperative period to face mask application for
induction in both groups
|