| CTRI Number |
CTRI/2024/04/065505 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study which compares two doses of dexmeditomedine drug in combination with fixed dose of ketamine drug delivered as intranasal spray in children for evaluating parental seperation without cry and ease of intravenous cannulation |
|
Scientific Title of Study
|
Prospective randomized atudy to compare two does of dexmedetomidine in
combination with standard dose ketamine delivered as atomised intranasal spray in paediatric
population for evaluating parental separation without cryand ease of intravenous cannulation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahalakshmi R |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesiology
Saveetha nagar, Thandalam, Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9943245009 |
| Fax |
|
| Email |
drmahalakshmi.rs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yachendra VSG |
| Designation |
Associate professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesiology Saveetha nagar, Thandalam, Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9790963362 |
| Fax |
|
| Email |
dr_yach@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mahalakshmi R |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesiology Saveetha nagar, Thandalam, Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9943245009 |
| Fax |
|
| Email |
drmahalakshmi.rs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mahalakshmi |
Saveetha medical college and hospital |
Department of Anaesthesiology Saveetha nagar, thandalam
Nh48 tamil nadu 602105
Chennai
TAMIL NADU |
9943245009
drmahalakshmi.rs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Asa1 and Asa2 volunteers |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intranasal dexmedetomidine and ketamine |
Comparing 2doses of dexmedetomidine 0.5mcg/kg and 1mcg/kg body weight with standard dose of ketamine 2mg/kg body weight |
| Intervention |
Mucosal atomiser spray |
Dexmedetomidine and ketamine combination is administered intranasally 45 minutes before procedure. 0.5ml is administered in each nostril |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA status 1and 2 |
|
| ExclusionCriteria |
| Details |
Children less than 1 year and more than 10years
Organ dysfunction
Congenital heart disease
Cardiac arrhythmia
Mental retardation |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of successful separation from mother using sedation score at 5minutes interval after premedication,
Ease of intravenous cannulation using FLACC scale
|
0 minutes , 5 minutes , 10 minutes, 15 minutes ,20 minutes and 30 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse effects,
Wakeup behaviour |
After extubation |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/04/2024 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the efficacy of two different doses of dexmedetomidine with fixed dose of ketamine given as a intranasal atomised spray for paediatric premedication and assessment of duration taken from administration of drug to calm separation of child from mother, assessment of ease of intravenous cannulation, wake up behaviour and adverse effects. |