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CTRI Number  CTRI/2026/02/104747 [Registered on: 25/02/2026] Trial Registered Prospectively
Last Modified On: 25/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of three sedation methods to improve comfort during dental treatment in children.  
Scientific Title of Study   Sedation Spectrum: Navigating Pediatric Comfort With Oral Midazolam, Intranasal Midasolam And Nitrous Oxide In Pediatric Dentistry. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajal Udaybhai Dave 
Designation  BDS, Post Graduate Student 
Affiliation  Government Dental College And Hospital, Ahmedabad 
Address  Government Dental College And Hospital, Ahmedabad Civil Hospital, Ahmedabad, Civil Hospital Campus, Civil Hospital Rd, Asarwa, Ahmedabad, Gujarat 380016

Ahmadabad
GUJARAT
380016
India 
Phone  8866442334  
Fax    
Email  daverajal3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shantanu Choudhari 
Designation  MDS, PhD 
Affiliation  Department of Pediatric and Preventive Dentistry,Government Dental College And Hospital, Ahmedabad 
Address  Government Dental College And Hospital, Ahmedabad Civil Hospital, Ahmedabad, Civil Hospital Campus, Civil Hospital Rd, Asarwa, Ahmedabad, Gujarat 380016

Ahmadabad
GUJARAT
380016
India 
Phone  9825666575  
Fax    
Email  shandent1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajal Udaybhai Dave 
Designation  BDS, Post Graduate Student 
Affiliation  Government Dental College And Hospital, Ahmedabad 
Address  Government Dental College And Hospital, Ahmedabad Civil Hospital, Ahmedabad, Civil Hospital Campus, Civil Hospital Rd, Asarwa, Ahmedabad, Gujarat 380016

Ahmadabad
GUJARAT
380016
India 
Phone  8866442334  
Fax    
Email  daverajal3@gmail.com  
 
Source of Monetary or Material Support  
Dr Rajal Udaybhai Dave 
 
Primary Sponsor  
Name  Dr. Rajal Udaybhai Dave 
Address  Government Dental College and Hospital, Ahmedabad Civil Hospital, Ahmedabad, Civil Hospital Campus, Civil Hospital Rd, Asarwa, Ahmedabad, Gujarat 380016  
Type of Sponsor  Other [Self] 
 
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 
Dr Rajal Udaybhai Dave  Government Dental College and Hospital, Ahmedabad  Floor no 5,Department of Pediatric and Preventive Dentistry, Government Dental College and Hospital, Civil Hospital, Ahmedabad, Civil Hospital Campus, Civil Hospital Rd, Asarwa, Ahmedabad, Gujarat 380016
Ahmadabad
GUJARAT 		 8866442334

daverajal3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT DENTAL COLLEGE AND HOSPITAL( IEC GDCH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No any systemic Disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intranasal Midazolam  Intranasal Midazolam in form of spray given in dose of 0.2mg/kg 
Comparator Agent  Nil  Nil 
Intervention  Nitrous Oxide - Oxygen combination  N2O given in inhalational form for conscious sedation in dose of 40%-50% Nitrous and 50%-60% Oxygen combination. 
Intervention  Oral Midazolam  Injection iv/im midazolam liquid mixed with glucose in dose of 0.5mg/kg. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1 Children aged 4 to 10 years
2 ASA 1 score & Frankl behavior rating 2
3 Need to undergo dental procedure like pulpectomy under local anesthesia
4 In whom non pharmacological behavior technique have not been successful
 
 
ExclusionCriteria 
Details  1 Who would not be cleared by anesthetist for sedation
2 Any known allergy or hypersensitivity reaction to the drugs being used
3 Who would be given any analgesics 6 hours before the procedure
4 Who would be recently administered drugs like erythromycin, clarithromycin, fluconazole or anticonvulsants which interfere with pharmacokinetics of midazolam
5 Any known case of any type of systemic medical illness like breathing difficulties, cognitive impairment, etc
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Oral and intranasal midazolam are expected to provide similar anxiolysis and sedation in children, though oral administration may show better acceptance. Oral midazolam and nitrous oxide are anticipated to have comparable clinical success in reducing anxiety. Intranasal midazolam may be as effective as nitrous oxide and serve as an alternative when mask tolerance is poor.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   10/03/2026 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

A total n= 90 anxious pediatric patients aged 4-10 years with Frankl behavior rating 2 & ASA 1 whose treatment require pulpotomy/pulpectomy would be randomized by chit picking method like 90 chits 30 of each group would be made and patient would be asked to pick one to receive oral midazolam (Group 1), intranasal midazolam (Group 2) & inhalational nitrous oxide – oxygen combination (Group 3).Total 90 patients are divided equally into 3 groups. Before enrollment of the patients into the study, the risks and benefits of the study would be explained to the parents/guardians and written consent would be obtained from the parents. The patient would be instructed to follow the pre procedural guidelines.Group 1 – would receive 0.5mg/kg oral midazolam (MIDAZOLAM HYDROCHLORIDE IV SOLUTION) combine with sweet orange flavored glucose syrup to avoid patients’ anxiety about having the medicine before treatment.Group 2 – would receive 0.5mg/kg intranasal midazolam spray (INSED ATOMIZER) using mucosal atomizer attached to the medicine itself.Group 3 - would receive nitrous oxide oxygen inhalation at concentration 40-60%.

Observational Parameters: Behavior of patient using Houpt’s sedation scale, Ramsay Sedation Scale, Acceptance of drug, Time of Onset of sedation and Parental satisfaction.


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