| CTRI Number |
CTRI/2020/05/025073 [Registered on: 08/05/2020] Trial Registered Prospectively |
| Last Modified On: |
29/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia
Dentistry
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
To check for acceptance of midazolam and lignocaine through nasal route |
|
Scientific Title of Study
|
Evaluation of Efficacy, Acceptance and Reactivity of Intranasal Midazolam with Lignocaine for Conscious Sedation in 5-8 year Old Children for Dental Procedures in Primary Teeth : A Clinical Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavana I |
| Designation |
Post Graduate Student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
r.no4 first floor Pediatric And Preventive Dentistry
KM Shah Dental College And Hospital
Vadodara
GUJARAT
391760
India |
| Phone |
7200330083 |
| Fax |
|
| Email |
bhavana.601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Dave |
| Designation |
HOD and professor pediatric and preventive dentistry |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
r.no4 first floor Pediatric And Preventive Dentistry
KM Shah Dental College And Hospital
Vadodara
GUJARAT
391760
India |
| Phone |
9998034036 |
| Fax |
|
| Email |
bhavnadave1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana I |
| Designation |
Post Graduate Student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
r.no4 first floor Pediatric And Preventive Dentistry
KM Shah Dental College And Hospital
Vadodara
GUJARAT
391760
India |
| Phone |
7200330083 |
| Fax |
|
| Email |
bhavana.601@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Shah Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Bhavana I |
| Address |
10 kothaval station street
chidambaram |
| Type of Sponsor |
Other [self funded] |
|
|
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 Bhavana I |
KM Shah Dental College And Hospital |
R.no4 first floor Pediatric And Preventive Dentistry
KM Shah Dental College And Hospital
Vadodara
GUJARAT |
7200330083
bhavana.601@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidhyapeeth Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients who require at least one restoration or extraction of grade II/III mobile primary tooth
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Midazolam with Lignocaine |
Intranasal Midazolam 0.2mg/kg one spray per nostril with Lignocaine 10% one spray per nostril
duration Press the plunger of the syringe quickly to administer about half of the volume as atomised spray into a nostril. Move the device over to the opposite nostril and administer the remaining medication into that nostril. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Frankle behaviour rating scale Class III or IV children will be included
Patient without any systemic illness
Preoperative heart rate of 55 to 100 beats per minute and Respiratory rate of 14 to 16 beats per minute
Maximum blood pressure reading of 140 100 mmHg
Patients who require at least one restoration or extraction of grade II or III mobile primary tooth
Parents giving consent for the study
|
|
| ExclusionCriteria |
| Details |
A history of any systemic disease where benzodiazepam is contraindicated
An upper respiratory tract infection with nasal discharge or respiratory distress
A history of allergy or intolerance to benzodiazepines
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The results of the present study will provide the dental professionals, the best evidence for co-relation of mode of intranasal sedation using INM with MAD |
outcome will be assessed/estimated at the time of adminstration of drug and post op with one day follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluate and acceptance of INM |
outcome will be assessed/estimated at the time of adminstration of drug and post op with one day follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2020 |
| Date of Study Completion (India) |
29/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Intranasal lidocaine and midazolam for procedural
sedation in children
Antonio Chiaretti, Giuseppe Barone et al
Arch Dis Child 2011;96:160–163 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Very young children often lack cooperative ability and need to be sedated for extensive dental treatment. Hence a needless and painless route of drug administration may be useful to obtain short-term sedation for diagnostic and painful procedures in uncooperative children which can be achieved by INM which is successfully used in a variety of Pediatric clinical situations.By INM with Lignocaine we can enhance the patient’s physical comfort and safety and to control anxiety and behavior, as well as to allow for the completion of the procedure this will lead better patient compliance |