| 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
|
|
|
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
|
|
|
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. |