| CTRI Number |
CTRI/2021/04/032662 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs dexmedetomidine and ketamine in children given through nose. |
|
Scientific Title of Study
|
Comparison of intranasal dexmedetomidine and ketamine for paediatric premedication: A randomized study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha kumari |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
doctornehakumari1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha kumari |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
doctornehakumari1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakash K Dubey |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences, Patna |
| Address |
Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
pkdubey@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura,Patna 800014 |
|
|
Primary Sponsor
|
| Name |
Neha Kumari |
| Address |
Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Patna |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Neha Kumari |
IGIMS, Patna |
First Floor, near OT complex, Department of Anaesthesiology
Patna
BIHAR |
7250574323
doctornehakumari1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intranasal Dexmedetomidine |
1 microgm/ Kg body weight, single dose, intranasal route, day of surgery |
| Intervention |
Intranasal ketamine |
5 mg/ Kg body weight, single dose, intranasal route, day of surgery |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
patients able to comprehend and willing to participate.
Patients of ASA physical status 1 and 2. |
|
| ExclusionCriteria |
| Details |
patients with known sensitivity to given drugs.
patients on concomitant anti arrhythmic or sedative medication.
patients with history of nausea/vomiting, apnoeic spells,cardiorespiratory and neurological illnesses. |
|
|
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 |
| FLACC scoring |
45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preoperative anxiety score, acceptance of intranasal delivery, sedation score and any adverse effect. |
60 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
26/04/2021 |
| 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
|
plan for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of intranasal dexmedetomidine and ketamine for paediatric premedication. This will enable us to decide the optimum drug for having a calm child before surgery. The study will include 100 paediatric patients. |