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CTRI Number  CTRI/2014/01/004335 [Registered on: 22/01/2014] Trial Registered Retrospectively
Last Modified On: 12/03/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Oral midazolam or intranasal dexmedetomidine in paediatric dental treatment 
Scientific Title of Study   A comparison of oral midazolam with intranasal dexmedetomidine in paediatric patients requiring restorative dental treatment 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MS/1318/8108 vesion 1 dated 22.09.2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek Jha 
Designation  Junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  netizen_18@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Babita Ghai 
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  9914209533  
Fax    
Email  ghaibabita@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Babita Ghai 
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12

Chandigarh
CHANDIGARH
160012
India 
Phone  9914209533  
Fax    
Email  ghaibabita@hotmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  4th Floor, Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh-160012, India 
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 Babita Ghai  Department of oral health  Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH 
9914209533

ghaibabita@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Review Committee, Postgraduate Institute of Medical Education And Research, Sector 12, Chandigarh-160012  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intranasal Dexmedetomidine  intranasal Dexmedetomidine 2.5mcg/kg along with oral plain honey was administered 25-30 minutes before start of dental procedure  
Comparator Agent  Oral midazolam  oral midazolam (0.5mg/kg) mixed in 5 ml of honey was administered along with intranasal saline 25-30 minutes before start of dental procedure  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  uncooperative children aged 2-6years who were scheduled for restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration  
 
ExclusionCriteria 
Details  Patients with previous exposure to dental sedation, neurodevelopmental anomalies, abnormal cardiac anatomy, Craniofacial anatomical defects , allergy to EMLA cream, allergy to study drugs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Dose of ketamine required to keep acceptable Houpts scores for procedure  during the 20-30 minutes of proceudre 
 
Secondary Outcome  
Outcome  TimePoints 
Ramsay sedation Scores, Heart rate, non invasive blood pressure  Ramsay sedation score-before premedication, and 15 and 30 minutes after premedication, after procedure
heart rate and non invasive blood pressure- at above mentioned times as well as during procedure
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/11/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Sedation is frequently desired in young children undergoing day-care dental treatments.Conscious sedation is a safe technique which offers sedation, relief of pain and anxiety with minimal systemic risks. Midazolam is the conventionally used sedative in a wide variety of applications. exmedetomidine is a newer alpha-2 agonist which provides sedation, analgesia and anxiolysis and has been used intravenously for pediatric procedural sedation in a variety of settings such as radiological imaging (MRI, CT Scan), awake craniotomies and cardiac catheterization.We planned this study to compare the efficacy of intranasal Dexmedetomidine with oral Midazolam for sedation in uncooperative children undergoing restorative dental procedures between 2-6 years of age. After institutional ethics committee approval, and written informed consent from parents, uncooperative children aged 2-6years were selected from the outpatient department of Oral Health Centre of our Institute. Only those children who were scheduled for restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration were enrolled for the study. Children were randomly assigned to two groups for premedication using computer-generated random number chart 20 mins after EMLA cream application.
Group D received intranasal Dexmedetomidine 2.5mcg/kg, (half the total dose loaded in a 2cc syringe undiluted in each nostril) and 5ml oral honey, as control. Group M received oral Midazolam 0.5mg/kg mixed with 5 ml honey and sterile water nasal drops (in a 2cc syringe equal volume in both nostrils) as control.
IV cannulation was attempted 30 minutes after premedication at the site pre-treated with EMLA cream. The children were then shifted to the dental chair and the child’s behavior during dental procedure was assessed using Houpt’s behavior rating scale of movement. A score of 3 was accepted as favourable. To score the overall behavior and outcome of treatment The Houpt’s overall behavior rating scale was used (Appendix 3).The optimum  score which was to be achieved was >3.A score of 5/6 was  considered as the best score. IV Ketamine boluses 0.5mg/kg were given till optimal sedation for the procedure is achieved. The duration of procedure and the total dose of the Ketamine administered was recorded.Intra-procedural vitals like HR, ECG, NIBP and Oxygen Saturation were monitored continuously at regular 10 minute intervals.The children were kept in observation area for a period of 60minutes after the end of the procedure. At the end of procedure, the dentist’s opinion was obtained for the overall experience in performing the procedure as either Good/Fair/Bad. The children were then discharged according to the modified Aldrette scoring criteria (Appendix 4). A score of 9/10 was considered as the sufficient criteria for discharge. The parents were contacted by making a telephone call in the evening to elicit any untoward effects or abnormality in the behaviour of their child. A note was made of the same, if any of these was present.

 
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