| CTRI Number |
CTRI/2025/05/087800 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different pre anaesthesia drugs for children under going dental treatment under General Anaesthesia |
|
Scientific Title of Study
|
Efficacy of Oral Midazolam vs. Fentanyl Lollipop as Premedication in Pediatric Full Mouth Rehabilitation Under General Anesthesia - A Pilot 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 |
Ayushma Chakravorty |
| Designation |
Post Graduate student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India Thiruvallur TAMIL NADU 600077 India
Thiruvallur
TAMIL NADU
575001
India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
8105571998 |
| Fax |
|
| Email |
ayushmac8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G Deepa Gurunathan |
| Designation |
Professor and Head of Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India Thiruvallur TAMIL NADU 600077 India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
G Deepa Gurunathan |
| Designation |
Professor and Head of Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India Thiruvallur TAMIL NADU 600077 India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored (Dr. Ayushma Chakravorty)
Infrastructure support-Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India Thiruvallur TAMIL NADU 600077 India |
|
|
Primary Sponsor
|
| Name |
Self sponsored Dr Ayushma Chakravorty |
| Address |
Conducted in clinic 28, department of prevention and Pediatric dentistry, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India
|
| 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 |
| G Deepa Gurunathan |
Saveetha Dental College and Hospital |
Clinic 28, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India Thiruvallur TAMIL NADU 600077 India Thiruvallur TAMIL NADU
Thiruvallur
TAMIL NADU
Thiruvallur
TAMIL NADU |
9994619386
deepag@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anxiety in children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl lollipop , given half an hour before surgery |
Fentanyl lollipops (oral transmucosal fentanyl citrate) are used as a non-invasive premedication to reduce anxiety and provide sedation in children before surgery, with rapid onset and ease of administration. |
| Comparator Agent |
Oral midazolam, given half an hour prior to surgery |
Midazolam is a water-soluble benzodiazepine and the most commonly used sedative premedicant in children. It has a rapid and reliable onset and antegrade amnesia with minimal respiratory depression. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Health human volunteers and are not under any medications.
Children who are indicated for full mouth rehabilitation under General Anaesthesia. |
|
| ExclusionCriteria |
| Details |
Children with systemic disorders, children above the age of 6, and children who are not indicated for full mouth rehabilitation under General Anaesthesia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parental separation and acceptance
Behaviour score at induction
Wake up behaviour score |
Parental separation and acceptance
Behaviour score at induction
Wake up behaviour score, at baseline , 30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
09/06/2025 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a study that to compare two pre anaesthetic medications given to Pediatric patients |