| CTRI Number |
CTRI/2026/01/100159 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Oral and Nasal Midazolam for Sedation in Children as a premedication |
|
Scientific Title of Study
|
A Comparative Study of Effectiveness of Oral Midazolam versus Intranasal Midazolam as Sedative Premedication in Pediatric Surgeries- A Prospective Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Senthil |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Salem |
| Address |
Room no-15,Anaesthesia department
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi, Salem TAMIL NADU
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanu |
| Designation |
Assistant professor |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem |
| Address |
Room no-15,Anaesthesia department,
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8056603011 |
| Fax |
|
| Email |
shanushanmugasundharam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V K Shobana |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem |
| Address |
Room no-15,Anaesthesia department,
Room no-15,Anaesthesia department,Vinayaka Missions Kirubanandha Variyar Medical College And Hospitals,Chinnaseergapadi,Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9597957880 |
| Fax |
|
| Email |
dr.shobana14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirubanandha Variyar Medical College & Hospitals,Salem |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupanandha Variyar Medical College and Hospitals |
| Address |
Chinnaseeragapadi Salem |
| Type of Sponsor |
Private 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 V K Shobana |
Vinayaka Missions Kirubanandha Variyar Medical College and Hospitals |
Room number 15 Department of Anaesthesia Chinnaseeragapadi Salem
Salem
TAMIL NADU |
9597957880
dr.shobana14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Salem |
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 |
| Comparator Agent |
Intranasal Midazolam as Sedative Premedication in Pediatric Surgeries |
Intranasal Midazolam as Sedative Premedication in Pediatric Surgeries |
| Comparator Agent |
midazolam as premedication in pediatric surgeries |
Comparison of oral vs Intranasal Midazolam |
| Comparator Agent |
Oral Midazolam as Sedative Premedication in Pediatric Surgeries |
Oral Midazolam as Sedative Premedication in Pediatric Surgeries |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled for Elective Surgeries under GA
ASA 1,2
Obtained Written Informed Consent from Patient or Legal Guardian
|
|
| ExclusionCriteria |
| Details |
History of Allergy or Hypersensitivity to Benzodiazepines
Childern with LRI or Nasal Pathology
Neurological disorders or Developmental Delay
Use of Sedatives within 48 hours prior to Surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the sedation effectiveness of Intranasal versus Oral Midazolam in Pediatric Patients undergoing Elective Surgery |
From 0 mins of administering midazolam till parentral separation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the onset of time and peak effect of sedation.To access anxiety levels at Parenteral separation.To evaluate mask acceptance score.To evaluate patients acceptability and adverse effects |
From 0 mins of Parentral Separation till Good Mask Acceptance |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/01/2026 |
| 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 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
|
This prospective randomized controlled study aims to compare the effectiveness of oral midazolam and intranasal midazolam as premedication in children undergoing surgery. The study will assess the level of sedation, anxiety reduction, ease of separation from parents, acceptance of anesthesia, and any side effects associated with each method.The results of this study will help determine the most effective, safe, and convenient route of administering midazolam as a premedication in pediatric surgical patients. |