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CTRI Number  CTRI/2017/12/010925 [Registered on: 20/12/2017] Trial Registered Retrospectively
Last Modified On: 18/07/2018
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   COMPARISON OF TWO MILD SLEEP MEDICINES (DEXMEDETOMIDINE GIVEN UNDER THE TONGUE AND MIDAZOLAM GIVEN AS AN ORAL SYRUP)TO CALM CHILDREN JUST BEFORE SURGERY 
Scientific Title of Study
Modification(s)  
Comparison of Atomized Sublingual Dexmedetomidine and Oral Midazolam as Preanaesthetic Medication in Children: A Prospective, 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  Pooja Bola Rajendra Devendra Kamath 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anaesthesiology, Kasturba Hospital, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9535675504  
Fax    
Email  poojakamath@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anitha Nileshwar 
Designation  Professor and Head 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anaesthesiology, Kasturba Hospital, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9880842121  
Fax  8202922428  
Email  anitharshenoy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pooja Bola Rajendra Devendra Kamath 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Anaesthesiology, Kasturba Hospital, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9535675504  
Fax    
Email  poojakamath@hotmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Academy of Higher Education, Manipal- 576104, Karnataka 
 
Primary Sponsor  
Name  Kasturba Hopsital Manipal 
Address  Kasturba Hospital Manipal, 576104. 
Type of Sponsor  Private 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 
DR Pooja Bola Rajendra Devendra Kamath  Kasturba Medical College   Department of Anaesthesiology, Kasturba Hospital, Manipal 576104.
Udupi
KARNATAKA 
9535675504

poojakamath@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Any child between the ages of 3 years to 7 years, weighing between 10-20 kilograms, undergoing elective minor surgery.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEXMEDETOMIDINE  Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist and possesses sedative, analgesic, perioperative sympatholytic, anaesthetic-sparing, and hemodynamic-stabilizing properties, but lacks respiratory depression,making it a useful and safe adjunct in diverse clinical applications. 
Comparator Agent  MIDAZOLAM  Midazolam, a γ-amino-butyric acid (GABA) receptor inhibitor, is the most commonly used sedative drug for premedication in children.Midazolam is a water-soluble benzodiazepine with rapid onset and short duration of action. It provides effective sedation, anxiolysis, and varying degrees of anterograde amnesia. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists Physical Status (ASA PS) 1 and 2, Weight 10 to 20 kg, Elective minor surgery under general anesthesia
 
 
ExclusionCriteria 
Details  American Society of Anesthesiologists Physical Status (ASA PS) 3 and 4, Weight < 10 kg or > 20 kg, Known allergy or hypersensitivity to dexmedetomidine, Parental/ Guardian refusal, Severe developmental delay or behavioural problems, Emergency cases, Cardiac arrhythmia or congenital heart disease, Surgeries more than 4 hour duration, Haemodynamic or respiratory instability, Children at risk for airway obstruction (obstructive sleep apnoea or a craniofacial syndrome), Any treatment with sedatives or anticonvulsants, Children who spit, vomited or refused sublingual administration of medication will also be excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Behaviour of the child on separation from parent (Modified Observer assessment of alertness and sedation scale- MOAA/S of 3 or 4)  At 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
- Acceptability of the drug via sublingual route
- Mask acceptance (Mask acceptance score of 1 or 2)
- Behaviour at time of wake-up from anaesthesia (Wake up behaviour score 1 or2)
 
At 2 years 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/09/2017 
Date of Study Completion (India) 28/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  

Preoperative anxiety is commonly seen in children coming for surgery with an incidence of at least 60%. Relieving pre and postoperative anxiety is an important concern for the paediatric anaesthesiologist.  Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist and possesses sedative, analgesic, perioperative sympatholytic, anaesthetic-sparing, and hemodynamic-stabilizing properties, but lacks respiratory depression,  making it a useful and safe adjunct in diverse clinical applications. Midazolam, a γ-amino-butyric acid (GABA) receptor inhibitor, is the most commonly used sedative drug for premedication in children. Midazolam is a water-soluble benzodiazepine with rapid onset and short duration of action. It provides effective sedation, anxiolysis, and varying degrees of anterograde amnesia.

Sublingual route has an advantage of mucosal absorption directly into the systemic circulation with no first pass hepatic metabolism due to the rich blood supply of oral mucosa, is easy to administer, has rapid action, reliable predictable effect and the drug is not destroyed by the gastrointestinal enzymes.

A mucosal atomiser device (MAD) delivers medications via a fine spray over a broad surface area. Higher drug serum levels are achieved when a drug is given in its atomized form, due to a more extensive distribution of the medication across the mucosa and increased bioavailability of the drug.  From the perspective of patient acceptance, administration of atomized spray has also been shown to produce significantly less aversive behaviour in young children, making it a practical option. 

The aim of this study is to compare the ease of child-parent separation between sublingual atomized dexmedetomidine and sublingual atomized midazolam groups. 

 
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