| CTRI Number |
CTRI/2025/12/098531 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Making Injections Easier for Kids: Midazolam vs. Lignocaine as Topical Agents |
|
Scientific Title of Study
|
"Comparative Evaluation of Pain Perception Using Midazolam and Lignocaine as Topical Agents Prior To IANB in Children Undergoing Pulpectomy " |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhi Lunawat |
| Designation |
Post-Graduate |
| Affiliation |
Pacific Dental College And Hospital, Debari |
| Address |
Department of pediatric and preventive dentistry
Pacific dental college and hospital, Debari, Udaipur - 313024 Department of pediatric and preventive dentistry,
Pacific dental college and hospital, Debari, Udaipur - 313024 Udaipur RAJASTHAN 313024 India |
| Phone |
9145194100 |
| Fax |
|
| Email |
siddhilunawat09@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
HOD PG GUIDE |
| Affiliation |
Pacific Dental College And Hospital, Debari |
| Address |
Department of pediatric and preventive dentistry, Room no 9 Pacific dental college and hospital, Debari, Udaipur - 313024 Udaipur RAJASTHAN 313024 India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dinesh Rao |
| Designation |
HOD PG GUIDE |
| Affiliation |
Pacific Dental College And Hospital, Debari |
| Address |
Department of pediatric and preventive dentistry, Room no 9 Pacific dental college and hospital, Debari, Udaipur - 313024 Udaipur RAJASTHAN 313024 India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debar, Udaipur Dist: Udaipur 313024 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatric and Preventive Dentistry |
| Address |
Department Of Pediatric And Preventive Dentistry, 1st Floor Pacific Dental College and Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Siddhi Lunawat |
SIDDHI LUNAWAT |
Department of pediatric and preventive dentistry, Room no 9
Pacific dental college and hospital, Debari, Udaipur - 313024
Department of pediatric and preventive dentistry, Room no 9
Pacific dental college and hospital, Debari, Udaipur - 313024 Udaipur RAJASTHAN |
09145194100
siddhilunawat09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Convener Research Review Board (IRRI Pacific Dental College & Hospital Debari,Udaipur 313024,Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
tooth caries
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine 7.5 ml |
Nummit Lignocaine Spray 7.5 ml in 1 puff of spray
|
| Comparator Agent |
Midazolam 1.25mg/0.1 ml |
Midazolam Buccal Spray 1.25mg/ 0.1ml will be measured by formula given by drug association and then that number of puffs will be delivered |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
healthy, co-operative children aged between 3-11 years,who needed pulpectomy in lower jaw |
|
| ExclusionCriteria |
| Details |
unco-operative children
special children
children wih swelling |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
pain perception
anesthesia onset and duration at 1 hr interval and 1 day follow up |
pain perception
anesthesia onset and duration at 1 hr interval and 1 day follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
27/12/2025 |
| 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="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
|
Aim: To evaluate pain perception by using Lignocaine and Midazolam as topical anaesthetic agents prior to inferior alveolar nerve block in 3–11 year old children undergoing pulpectomy procedures Introduction: Inferior alveolar nerve block (IANB) is one of the most commonly used local anaesthesia techniques in paediatric dentistry but remains highly anxiety-provoking and painful for children. Conventional topical anaesthetics, primarily Lignocaine, provide only partial relief. Midazolam, a benzodiazepine with sedative and anxiolytic properties, has recently been explored for its potential topical anaesthetic effect on oral mucosa. Methodology: A randomized controlled clinical trial was conducted on 80 children aged between 3–11 years requiring pulpectomy in mandibular primary molars. Participants were randomly assigned into two groups: Group A ( Lignocaine spray ) and Group B (Midazolam spray ) applied for a minute before IANB. Pain perception during injection was assessed using the SEM scale. The time until the area was anesthetized was also measured in minutes. Results: Children in the Midazolam group demonstrated significantly lower pain scores on SEM scale when compared with Lignocaine group. Also there were no post-anaesthetic complications in any of the children. Conclusion: Thus, topical Midazolam demonstrated superior efficacy compared to Lignocaine in reducing pain and anxiety during IANB in young children. Its dual action as a topical anaesthetic and anxiolytic makes it a promising adjunct for paediatric dentistry. |