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CTRI Number  CTRI/2024/01/061815 [Registered on: 24/01/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Intranasal sedation and Nitrous oxide-Oxygen inhalation sedation for 5-10 year old Anxious Children Undergoing Dental Treatment 
Scientific Title of Study   Comparative Evaluation of Intranasal Dexmedetomidine-Ketamine, Ketamine-Midazolam and Nitrous oxide-Oxygen inhalation for conscious sedation of 5-10 year old Anxious Children Undergoing Dental Treatment: A Randomised 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  Nandini Devi M 
Designation  Postgraduate student 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Pediatric and Preventive Dentistry,Clinic-28,162,Poonamallee high road,Velappanchavadi

Chennai
TAMIL NADU
600077
India 
Phone  6380593906  
Fax    
Email  mnandinidevi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrGanesh Jeevanandan 
Designation  Professor 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Pediatric and Preventive Dentistry,Clinic-28,162,Poonamallee high road,Velappanchavadi

Chennai
TAMIL NADU
600077
India 
Phone  9884293869  
Fax    
Email  helloganz@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrGanesh Jeevanandan 
Designation  Professor 
Affiliation  Saveetha Dental College and Hospitals 
Address  Department of Pediatric and Preventive Dentistry,Clinic-28,162,Poonamallee high road,Velappanchavadi

Chennai
TAMIL NADU
600077
India 
Phone  9884293869  
Fax    
Email  helloganz@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Dental College and Hospital , 162 , Poonamallee high road, Velapanchavadi, Chennai-600077 
 
Primary Sponsor  
Name  Saveetha Dental College and Hospital 
Address  162, Poonamallee high road,Velappanchavadi, Chennai-600077,Tamil Nadu  
Type of Sponsor  Research institution and hospital 
 
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 Nandini Devi M  Saveetha Dental College and Hospital  Clinic No.28,Department of Pediatric and Preventive Dentistry,162,Poonamallee high road,Velappanchavadi
Chennai
TAMIL NADU 		 6380593906

mnandinidevi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Dental College-Institutional Human Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intranasal dexmedetomidine-ketamine  Intranasal drug combination delivered to anxious children requiring pulp therapy before start of treatment using mucosal atomisation device Dexmedetomine dose 4 microgram per kilogram body weight Ketamine dose 3 milligram per kilogram body weight Total duration of the procedure less than one hour 
Comparator Agent  Intranasal ketamine-midazolam  Intranasal drug combination delivered to anxious children requiring pulp therapy before start of treatment using mucosal atomisation device Ketamine dose - 3 milligram per kilogram body weight Midazolam dose 0.2 milligram per kilogram body weight.Total duration of the procedure less than one hour. 
Intervention  Nitrous oxide-oxygen  Inhalation sedation delivered to anxious children requiring pulp therapy before start of treatment .Total duration of the procedure less than one hour. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  ASA 1
Frankl behaviour rating 1
Pulpotomy
Pulpectomy
 
 
ExclusionCriteria 
Details  Not cleared by anaesthetist for sedation
Any known allergy,hypersensitive reaction
Recent administration of erythromycin,anticonvulsant - as they may interfere with pharmacokinetics of midazolam,ketamine 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Level of sedation  Before start of treatment , After administration of local anaesthetic , during biomechanical preparation , after completion of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Behaviour rating  Before start of treatment , After administration of local anaesthetic , during biomechanical preparation , after completion of treatment. 
total sedation time  from onset of sedation to recovery (in minutes) 
Pulse rate (in bpm)  At start ,10 minutes, 20 minutes, 30 minutes , 40 minutes , 50 minutes, 60 minutes, 70 minutes , 80 minutes , at time of discharge 
Oxygen Saturation  At start ,10 minutes, 20 minutes, 30 minutes , 40 minutes , 50 minutes, 60 minutes, 70 minutes , 80 minutes , at time of discharge 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   29/01/2024 
Date of Study Completion (India) 12/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 12/04/2024 
Estimated Duration of Trial   Years="0"
Months="9"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mnandinidevi@gmail.com].

  6. For how long will this data be available start date provided 28-12-2023 and end date provided 29-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Any medical or dental procedure aims to complete treatment with least or no discomfort. In pediatric patiets , anxiety and fear are the most common reasons for difficulty in behaviour management.There are two different kinds of behaviour management techniques - non pharmacological and pharmacological.When non pharmacological behvaiour management techniques fail , pharmacological sedatives are used as alternatives.There are various drugs and routes of administration employed.In this study the intranasal route is opted as it is non-invasive ,less traumatic to pediatric patients and has faster onset as it bypassess the first pass metabolism.Previous literature showed evidence of individual drugs used for intranasal sedation . In this study combination of such drugs(dexmedetomidine-ketamine and ketamine-midazolam) are used to check if there are any added advantages such as faster onset of sedation and recovery.And also to check if one drug overcomes the disadvantage of another.For example, midazolam casues bradycardia ad ketamine causes tachycardia,the combination might cause a nullification of the individual effects.  
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