| CTRI Number |
CTRI/2024/07/069940 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparative Evaluation Of Two Intranasal sleep inducing/calming Agents Among Children Undergoing Invasive Dental Procedures |
|
Scientific Title of Study
|
Comparative Evaluation Of Two Intranasal Sedative Agents Among Children Undergoing Invasive Dental Procedures: A Crossover Split Mouth Randomized Clinical Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KASHYAP B |
| Designation |
Student |
| Affiliation |
Student, Department of Pedodontics |
| Address |
Department of Pedodontics,
Room No.4
AME Dental College Raichur
Bijangera road
584103
Raichur
KARNATAKA
584103
India |
| Phone |
9481682945 |
| Fax |
|
| Email |
kashyapkannanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAGHAVENDRA HAVALE |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Department of Pedodontics |
| Address |
Department of Pedodontics
Room No.4
AME dental college
Bijangera road
Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAVEEN KUMAR N H |
| Designation |
Reader |
| Affiliation |
Department of Pedodontics |
| Address |
Department of Pedodontics
Room No.4
AME dental college
Bijangera road
Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9538623728 |
| Fax |
|
| Email |
drpraveennh@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMES dental college
Bijangera road
Raichur
Karnataka , India -584103 |
|
|
Primary Sponsor
|
| Name |
Kashyap B |
| Address |
AMES dental college
Bijangera road
Raichur
Karnataka , India -584103 |
| Type of Sponsor |
Other [self] |
|
|
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 Kashyap B |
AME Dental College Raichur |
room no 4 department
of pedodontics AMEs
Dental college and
Hospital bijingera road
Raichur
Raichur
KARNATAKA
Raichur
KARNATAKA |
9481682945
kashyapkannanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for AME denatl college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
00170 code for anesthesia for dental procedures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Dexmedetomidine |
1 minute after Internasal application with atomization device which is monitored for 3 days |
| Comparator Agent |
Intranasal midazolam |
1 minute after application with atomization device which is monitored for 3 days |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Anxious paediatric patients aged 4–10 years with negative and definitely negative behavioural rating.
Belonging to American society of Anaesthesiologists (ASA) physical status I.
Whose treatment requires bilateral pulp therapy (pulpotomy/pulpectomy) in lower two quadrants under inferior alveolar nerve block. Whose treatment requires bilateral extraction in lower two quadrants under inferior alveolar nerve block
Children with no enlarged tonsils, no problem with neck movements and no oversized tongue.
Children with optimal SpO2 saturation.
Treatment modality only for first or second primary molars on both the sides
|
|
| ExclusionCriteria |
| Details |
Children with cognitive impairment
Breathing difficulties,
History of systemic illness,
Hypersensitivity to midazolam/
Children with congenital heart disease.
Children on central nervous system (CNS) depressant drugs
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of intranasal dexmedetomidine and intranasal midazolam paediatric dental patients undergoing pulp therapies and extraction |
preoperative, 5 minutes after application and postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate & compare the rate of acceptance & side effects of intranasal sedative agents. |
Preoperative 5 minutes after application & postoperative |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
04/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim: The
Aim of the study is to compare and evaluate the effect of intranasal
dexmedetomidine and intranasal midazolam as a conscious sedation among children
with the 4-10 years Methodology Patients that come under
inclusion criteria are allotted to the groups. Then samples are subjected to stratified
block randomisation based on the order of the study.The study sample, examiner
and analyser are blinded. The drug will be administered with the help of
atomisation device. The drug acceptance and side effects will be recorded
according to scale given by Rakaf et. al 2001. The rate of sedation
and behaviour will be analysed using Houpt behaviour scale at preoperative,
intraoperative and postoperative period. The mean data will be recorded and
data will be subjected to statistical analysis. |