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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
[Ma1]  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.


 [Ma1]

 
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