| CTRI Number |
CTRI/2025/12/099174 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine in Children aged 5 to 14 years for Procedural Sedation |
|
Scientific Title of Study
|
A Randomised Control Trial comparing the Efficacy and Safety of Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine for Procedural Sedation in children aged 5-14 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kapil Bhalla |
| Designation |
Professor |
| Affiliation |
|
| Address |
Ward 14, Department of Paediatrics
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak Haryana 124001
Rohtak
HARYANA
124001
India |
| Phone |
9813743565 |
| Fax |
|
| Email |
kapil_bhalla@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhaviya |
| Designation |
Post Graduate |
| Affiliation |
|
| Address |
Ward 14, Department of Paediatrics
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak Haryana 124001
Rohtak
HARYANA
124001
India |
| Phone |
7206793118 |
| Fax |
|
| Email |
bhaviyarm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhaviya |
| Designation |
Post Graduate |
| Affiliation |
|
| Address |
Ward 14, Department of Paediatrics
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak Haryana 124001
Rohtak
HARYANA
124001
India |
| Phone |
7206793118 |
| Fax |
|
| Email |
bhaviyarm@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) |
| Address |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) Rohtak Haryana 124001 |
| 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 Bhaviya |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak |
Ward 14 Department of Paediatrics
Rohtak
HARYANA |
7206793118
bhaviyarm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Atomised intranasal Dexmedetomidine |
Dexmedetomidine 2mcg/kg/dose will be given through intranasal route in Atomised form 30 minutes prior to painful procedures |
| Comparator Agent |
Intranasal Atomised ketamine |
Ketamine 3mg/kg/dose via Atomised intranasal route 30 minutes prior to painful procedures |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5 -14 years having ASA physical status 1 and 2 as per ASA guidelines |
|
| ExclusionCriteria |
| Details |
1-Any known allergy to drug
2- Children having Severe Liver or Renal Insufficiency
3- Severe bradycardia or atrioventricular block above II degree type 2
4- Children whose parents refuse to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depth of Sedation |
120 minutes or till clinical recovery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of recovery from sedation |
30,45,60,75,90,105,120 minutes |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
01/01/2026 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The index Clincal trial "Atomised Intranasal Dexmedetomidine versus Atomised Intranasal Ketamine in Children aged 5-14 years for Procedural Sedation" will be a Randomised Control Trial and is being registered in Clinical Trial Registry of India will be carried out in Department of Paediatrics PGIMS Rohtak with complete adherence to Clinical Trial protocols PI Dr. Kapil Bhalla , Co PI Dr. Bhaviya . The trial results will be avaliable in public domain and any clinical deviation if any, will be duly reported. Total duration of trial will be 9 months from the date of generation of ctri number |