| CTRI Number |
CTRI/2026/03/105433 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
evaluation of amnesic produced by oral midazolam and intranasal dexmedetomidine in pediatric patients: a randomized clinical study |
|
Scientific Title of Study
|
amnesic effect of oral midazolam and intranasal dexmedetomidine in children: a randomized clinical 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 |
pooja nellore |
| Designation |
Post Graduate student |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Kasturba Medical College, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Kasturba Medical College, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9581224480 |
| Fax |
|
| Email |
poojanellore94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwin Rao |
| Designation |
Head of the department |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Kasturba Medical College, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Kasturba Medical College, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9581224480 |
| Fax |
|
| Email |
poojanellore94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
pooja nellore |
| Designation |
Post Graduate student |
| Affiliation |
Manipal College of Dental Sciences Mangalore |
| Address |
Kasturba Medical College, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Kasturba Medical College, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9581224480 |
| Fax |
|
| Email |
poojanellore94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
pooja nellore |
| Address |
Kasturba Medical College, Light House Hill Road, Hampankatta, Mangalore, Karnataka 575001 |
| Type of Sponsor |
Other [Postgraduate student] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
kmc, light house hill road, mangalore, hampankatta 575001. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr pooja nellore |
Manipal College of Dental Sciences Mangalore |
Dr. pooja nellore, department of pediatric and preventive dentistry, second floor, manipal college of dental sciences, mangalore, karnataka 575001.
Dakshina Kannada
KARNATAKA |
9581224480
poojanellore94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Manipal College of Dental Sciences Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intranasal dexmedetomidine amnesic effect |
to evaluate the anterograde amnesic effect in patients administered intranasal dexmedetomidine in dental treatment in a duration of 1 year |
| Comparator Agent |
oral midazolam amnesic effect |
to evaluate the anterograde amnesic effect in patients administered with oral midazolam during dental treatment. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
ASA category - 1
childs weight within normal range
frankls positive or negative behavior
children with at least 2 carious lesions |
|
| ExclusionCriteria |
| Details |
children with identifiable risk factors for airway obstruction, such as enlarged tonsils or adenoids, nasal polyps, septal deviation and a mallampati score of 3 or 4 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| amnesic effect of midazolam compared to dexmedetomidine. |
assessed every 15 minutes till the procedure ends. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ramsay sedation scoring |
15 minutes after administration of the drug |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To evaluate the amnestic effect of oral midazolam using amnesia test. To evaluate the amnestic effect of intranasal dexmedetomidine using amnesia test. To compare the amnestic effect of oral midazolam and intranasal dexmedetomidine. |