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CTRI Number  CTRI/2018/04/013123 [Registered on: 09/04/2018] Trial Registered Retrospectively
Last Modified On: 18/02/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   a comparative evaluation of intranasal dexmedetomidine vs midazolam for preoperative sedation in children 
Scientific Title of Study   A Comparative Evaluation Of Intranasal Dexmedetomidine & Intranasal Midazolam For Premedication In Children A Double Blind Randomised Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arcojit Ghosh 
Designation  Post Graduate Trainee 
Affiliation  R G Kar Medical College & Hospital Kolkata 
Address  Department of Pharmacology R G Kar Medical College and Hospital Kolkata

Kolkata
WEST BENGAL
700004
India 
Phone  9830245087  
Fax    
Email  arcojitg@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Asoke Kumar Das 
Designation  Associate Professor 
Affiliation  R G Kar Medical College & Hospital Kolkata 
Address  Department of Pharmacology R G Kar Medical College & Hospital Kolkata

Kolkata
WEST BENGAL
700004
India 
Phone  9733050609  
Fax    
Email  dr.askd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arcojit Ghosh 
Designation  post graduate trainee 
Affiliation  r g kar medical college & hospital kolkata 
Address  department of Pharmacology R G Kar Medical College Kolkata-700004

South Twentyfour Parganas
WEST BENGAL
700084
India 
Phone  9830245087  
Fax    
Email  arcojitg@gmail.com  
 
Source of Monetary or Material Support  
R G Kar Medical College & Hospital Kolkata-700004 
 
Primary Sponsor  
Name  R G Kar Medical College Hospital Kolkata 
Address  R G Kar Medical College & Hospital 1 Khudiram Bose Sarani kolkata 4 
Type of Sponsor  Government medical college 
 
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 
Arcojit Ghosh  R G Kar Medical College & Hospital, Kolkata  Recovery room for Pediatric Surgery OT, functioning under Department of Anesthesiology 8th floor, emergency building, R G Kar Medical College & Hospital
Kolkata
WEST BENGAL 
9830245087

arcojitg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
r g kar medical college & hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  All children belonging to ASA 1 health status,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine  100 mcg/ml vials used. drug was diluted to desirable doses using distilled water. dose used in this study 2 mcg/kg 
Comparator Agent  midazolam  5 mg/ml vials were used. drug was diluted to desirable doses by distilled water. dose used was 0.5 mg/kg 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children aged 2-8 yrs belonging to ASA physical status I or II scheduled for elective surgery 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
satisfactory sedation score achieved at the time of induction   45 mins after administration of drug 
 
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   Phase 4 
Date of First Enrollment (India)   26/04/2013 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

OBJECTIVES: The study aimed at comparing the efficacies of intranasal dexmedetomidine & intranasal midazolam regarding producing sedation at induction. The secondary end- points were preoperative heart rate & systolic bloos pressure changes after administration of either drugs. We also looked at sedation & analgesia status at the time of induction, recovery as well as 3 hours & 6 hours post operatively.

METHODS: Study subjects comprised of children aged 2-8 years posted for elective surgery under general anesthesia. It was a double blind randomized control trial comprising of 90 subjects divided into 2 groups. group A (n=42) received 0.2 μg/kg dexmedetomidine & group B (n=48) 0.5 mg/kg midazolam by intranasal route 45 minutes prior to induction. sedation & analgesia scores were assessed by Ramsay Sedation Scale & Observer Pain Scale respectively. heart rate & systolic blood pressures were recorded every 15 minutes pre- operatively after administration of drugs. sedation & analgesia scores were recorded at induction, recovery, after 3 hours & 6 hours post operatively.

RESULTS: 93% subjects in group A & 60% in group B achieved satisfactory sedation at the time of induction. Sedation status & analgesia obtained at the time of induction, recovery, 3 hours & 6 hours post operatively were significantly better in group A. Pre- operative changes in HR & SBP in both groups were comparable.

CONCLUSION: Intranasal dexmedetomidine is safe &more effective than intranasal midazolam for pre operative sedation in children. Also, intranasal dexmedetomidine is a superior agent than intranasal midazolam for post operative analgesia in pediatric population.

 
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