| CTRI Number |
CTRI/2021/11/037896 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between DEXMEDITOMIDINE and KETAMINE premedication intranasaly for intravenous access in children |
|
Scientific Title of Study
|
Comparison between intranasal DEXMEDITOMIDINE versus intranasal KETAMINE as premedication for intravenous access in children-Randamised control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnilin Joey |
| Designation |
Junior resident |
| Affiliation |
Dr.Dy Patil medical college & research centre |
| Address |
Dept of Anaesthesiology
Dr.Dy Patil medical college
Sant Tukaram nagar
Pimpri-chinchwad
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9751221626 |
| Fax |
|
| Email |
anilinjoey@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipul K Sharma |
| Designation |
Professor & HOD cardiac anaesthesia |
| Affiliation |
Patil medical college & research centre |
| Address |
Dept of Anaesthesiology
Dr.Dy Patil medical college
Sant Tukaram nagar
Pimpri-chinchwad
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7251888789 |
| Fax |
|
| Email |
vipulsharmacta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipul K Sharma |
| Designation |
Professor & HOD cardiac anaesthesia |
| Affiliation |
Patil medical college & research centre |
| Address |
Dept of Anaesthesiology
Dr.Dy Patil medical college
Sant Tukaram nagar
Pimpri-chinchwad
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7251888789 |
| Fax |
|
| Email |
vipulsharmacta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy;high tech OT;5th floor |
|
|
Primary Sponsor
|
| Name |
DrAnilin Joeyself |
| Address |
Dr.Dy Patil medical college & Reearch centre,Pimpri chinchwad,pune |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrAnilin joey |
Hi tech OT complex,5thfloor,deptof anaesthesia,Dr.Dy Patil medical college |
Dr.Dy Patil medical college hospital and research centre,Pimpri chichwad,Pune
Pune
MAHARASHTRA |
9751221626
anilinjoey@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics sub committee Dr.Dy Patil medical college and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison between intranasal DEXMEDITOMIDINE versus intranasal ketamine as premedication for intravenous access in children-Randomised controll study |
Aim is to compare the efficacy of intra nasal DEXMEDITOMIDINE versus intranasal ketamine to facilitate the intravenous access in children |
| Comparator Agent |
Intranasal DEXMEDITOMIDINE |
Intranasal DEXMEDITOMIDINE to facilitate the intravenous access in children
Dose-2mcg/kgbw
Route:intranasal |
| Comparator Agent |
Intranasal KETAMINE |
Intranasal KETAMINE to facilitate the intravenous access in children
Dose-5mg/Kgbw
Route:intranasal |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 3 months to 5 years
2.ASA grade 1 &2&3
3.Weight of the patient being in normal range for that age and sex |
|
| ExclusionCriteria |
| Details |
1)Patients with ASA physical status IV or more.
2) Patients with any neurological and psychiatric disorders.
3) History of allergy to any of the drugs being used under study.
4) Unwilling patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of intranasal DEXMEDITOMIDINE to facilitate the intravenous access in children |
Sedation score:
Grade1-10minute-separation from mother
Grade2- 10-20minutes-Awake but separated easily
Grade3-20-30minutes-Difficult to separate easily |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of intranasal KETAMINE to facilitate the intravenous access in children |
Sedation score:
Grade1-10minute-separation from mother
Grade2- 10-20minutes-Awake but separated easily
Grade3-20-30minutes-Difficult to separate easily |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomised,prospective,comparative,double blinded observational study wherein intranasal DEXMEDITOMIDINE and Ketamine are compared to facilitate the intravenous access in children. |