| CTRI Number |
CTRI/2025/10/096396 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intramuscular versus Intravenous Ketamine and Dexmedetomidine for sedation in children undergoing MRI:A comparative study |
|
Scientific Title of Study
|
Comparison of the efficacy of intramuscular versus intravenous combined Ketamine and Dexmedetomidine for sedation in Pediatric patients undergoing MRI: A prospective randomized comparative clinical study. |
| 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 Rina B Gameti |
| Designation |
Tutor |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department of anesthesiology Government Medical College Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825229398 |
| Fax |
|
| Email |
drrinaninama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumud S Ganvit |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department of anesthesiology Government Medical College Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825607625 |
| Fax |
|
| Email |
drkumudsganvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumud S Ganvit |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College Vadodara |
| Address |
Department of anesthesiology Government Medical College Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825607625 |
| Fax |
|
| Email |
drkumudsganvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology Government Medical College Vadodara,Gujarat,India-390001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College Vadodara |
| Address |
Department of anesthesiology Government Medical College Vadodara,Gujarat,India-390001 |
| 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 Rina B Gameti |
Government Medical College Vadodara |
Radiology Department,Ground Floor,New Surgical Block, Government Medical College Campus,Vadodara-390001
Vadodara
GUJARAT |
9825229398
drrinaninama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for Biomedical and health research,government medical college baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficasy of combined injection Ketamine and Dexmedetomidine intramuscularly for sedation in pediatric patients undergoing MRI |
Injection Ketamine 3-4mg/kg and injection Dexmedetomidine 1-1.5microgram/kg Drugs will be taken undiluted in 1ml Insulin syringe for accurate dosages then volume of drugs to be taken into 2ml syringe and given intramuscularly on the anterolateral aspect of the thigh 6-8minutes before the procedure Ramsay sedation score 5 would be achieved 6-8minutes after intramuscular dosage of the drugs where patient would asleep and adequately sedated for MRI Maintenance of sedation during the procedure will be maintained by injection Ketamine dose of 0.5mg/kg when patient will move or MRI scaning show motion artifact |
| Intervention |
Efficasy of combined injection Ketamine and Dexmedetomidine intravenously for sedation in pediatric patients undergoing MRI |
Injection Ketamine 0.5-1mg/kg and injection Dexmedetomidine 0.3-0.5microgram/kg Drugs will be taken undiluted in 1ml Insulin syringe for accurate dosages then volume of drugs to be taken into 2ml syringe and given intravenously 2-3minutes before procedure Ramsay sedation score 5 would be achieved 2-3minutes after intravenous dosage of the drugs where patient would asleep and adequately sedated for MRI Maintenance of sedation during the procedure will be maintained by injection Ketamine dose of 0.5mg/kg when patient will move or MRI scaning show motion artifact |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Age group 6months to 8 years of either gender Patients with ASA I-II-III status
Scheduleded to undergo MRI with time less than 60 mins
Able to provide written informed consent by relatives |
|
| ExclusionCriteria |
| Details |
Not able to provide written informed consent by relatives
Hypersensitivity to drugs used in the study
Presence of congenital heart diseases and pulmonary diseases
Recent upper respiratory tract infections or pneumonia
Facial malformation and anticipatory difficult intubation
Extreme tonsillar hypertrophy
Raised intracranial tension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the quality of sedation acheived by intamuscular versus intravenous injection ketamine and inj dexmedetomidine combination in peadiatric patients undergoing MRI as assessed by image quality |
3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic stablity heart rate and oxygen saturation
Duration of MRI scan and number of rescue bolus required
Recovery profile according to modified aldrete score
Adverse effects like bradycardia and desaturation and any other complications |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/10/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
EFFICACY OF COMBINED INJ KETAMINE AND INJ DEXMEDETOMIDINE INTRAVENOUSLY VERSUS INTRAMUSCULARLY FOR SEDATION IN PEADIATRIC PATIENTS UNDERGOING MRI
Dose of drugs used intravenously Inj ketamine 0.5 - 1 mg/kg and Inj dexmedetomidine 0.3 -0.5 microgram/kg
Dose of drugs used intramuscularly Inj ketamine 3 - 4mg/kg and Inj Dexmedetomidine 1 -1.5 microgram/kg
In both the groups Ramsay sedation score 5 would be achieved
In both the groups maintainance dose of inj ketamine 0.5mg/kg is intravenously if the patient moves or MRI scan shows any motion artifect
Recovery profile will be accessed by Modified Alderate score if 9 or more than 9
Hemodynamic stablity and adverse effects are monitored |