| CTRI Number |
CTRI/2024/05/066640 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| 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 two drug dexmedetomidine and ketamine for sedation in pediatric population via intranasal atomisor in pediatric patient undergoing surgical procedure |
|
Scientific Title of Study
|
“Comparison of the efficacy of intranasal atomised dexmedetomidine versus intranasal atomised ketamine as a premedication for sedation and anxiolysis in pediatric undergoing surgical procedure. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubam Achari |
| Designation |
Junior Resident |
| Affiliation |
Maharani laxmi bai medical college jhansi |
| Address |
Room no 22 senior boys hostel maharani laxmi bai medical college jhansi uttarpradesh
Department of anesthesia
maharani laxmi bai medical college jhansi uttarpradesh
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
8123359024 |
| Fax |
|
| Email |
shubam007achari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chavi Sehgal |
| Designation |
Associate Professor |
| Affiliation |
Maharani laxmi bai medical college jhansi |
| Address |
Department of anesthesia
maharani laxmi bai medical college jhansi uttarpradesh
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
9935370472 |
| Fax |
|
| Email |
dr_chavi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chavi Sehgal |
| Designation |
Associate Professor |
| Affiliation |
Maharani laxmi bai medical college jhansi |
| Address |
Department of anesthesia
maharani laxmi bai medical college jhansi uttarpradesh
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
9935370472 |
| Fax |
|
| Email |
dr_chavi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia and Critical care
maharani laxmi bai medical college jhansi uttarpradesh India 284128 |
|
|
Primary Sponsor
|
| Name |
Maharani laxmi bai medical college jhansi |
| Address |
Department of anesthesia
maharani laxmi bai medical college jhansi uttarpradesh India 284128 |
| Type of Sponsor |
Government 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 shubam achari |
Maharani Laxmi Bai medical college jhansi |
Department of anaesthesia
Jhansi
UTTAR PRADESH |
8123359024
shubam007achari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharani Laxmi Bai Medical College Jhansi |
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 |
| Intervention |
Dexmedetomidine |
Dose 2.5mcg/kg via intranasal atomizer for 2 month duration of study |
| Comparator Agent |
Ketamine |
Dose 5mg/kg via intranasal atomizer for 2 month duration of study |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Written informed consent,ASA 1and 2 patients,Age between 1-10years,Normal coagulation status
|
|
| ExclusionCriteria |
| Details |
Not given written informed consent,ASA status 3 and 4 ,Abnormal coagulation,Hemodynamically unstable ,Hematological,cardiovascular disorder ,allergy or contraindication of study drugs,history of seizure,upper respiratory tract infection,Arnold chiari malformation,Active liver disease,Difficult airway,Intellectual disabiltiy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the degree of sedation provided by the administration of intranasal atomized dexmedetomidine and ketamine in both group. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the ease of parental separation and venous cannulation in both groups along with the degree of successful mask acceptance , perioperative vital parameter, along with incidence of emergency agitation. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
12/05/2024 |
| Date of Study Completion (India) |
22/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Patients were randomised into two groups using random
allocation software. Patients assigned to Group I received intranasal atomised
dexmedetomidine 2.5mg/kg , 30 min before induction. Patients in Group II
received intranasal atomised ketamine 5mg/kg 30 min before induction.
Both the study drugs were diluted to 2 ml with 0.9%
normal saline and taken in a 2 ml syringe and 0.1 ml extra volume was added to
account for the dead space of the atomiser.
A detailed pre-anaesthetic evaluation was done and
adequate fasting as per standard guidelines was ensured.
The calculated dose of the study drugs was administered
using a 2 ml syringe and the mucosal atomisation device.
We administered half of the dose in one nostril and the
other half in the other nostril in an upward and outward direction with the
child in the supine position.
Sedation was assessed at 10, 20 and 30 min in both groups
using the UMSS which is a simple, valid and reliable tool that facilitates
rapid assessment and documentation of depth of sedation in children and a score
of 2 was considered satisfactory.
|