| CTRI Number |
CTRI/2025/08/092844 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Sedation for MRI in children:a comparison of Ketamine–Dexmedetomidine and Ketamine–Midazolam |
|
Scientific Title of Study
|
Premedication in paediatric patients undergoing MRI: comparative study of intramuscular ketamine 3mg/kg with dexmedetomidine 1.5mcg/kg versus ketamine 3mg/kg with midazolam 0.05mg/kg |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuja Gopi |
| Designation |
Resident Doctor |
| Affiliation |
Sri Satya Sai Institute of Higher Medical Sciences |
| Address |
Edathara house
Vakery p o
Sulthan Bathery
Wayanad, kerala
Wayanad
KERALA
673592
India |
| Phone |
8921602741 |
| Fax |
|
| Email |
anujagopi.online@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kolli S Chalam |
| Designation |
Senior Consultant |
| Affiliation |
Sri Satya Sai Institute of Higher Medical Sciences |
| Address |
Sri Sathya Sai Institute of Higher Medical Sciences
EPIP Area, Whitefield, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9945210967 |
| Fax |
|
| Email |
chalam.k@sssihms.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrushali Choudhary |
| Designation |
Additional Senior Consultant |
| Affiliation |
Sri Satya Sai Institute of Higher Medical Sciences |
| Address |
Sri Sathya Sai Institute of Higher Medical Sciences
EPIP Area, Whitefield, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
8308836873 |
| Fax |
|
| Email |
choudhary.vrushali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sathya Sai Institute of Higher Medical Sciences
KIADB Export Promotion Industrial Area,Whitefield,Bengaluru,Karnataka ,India
pin:560066 |
|
|
Primary Sponsor
|
| Name |
Sri Sathya Sai Institute of Higher Medical Sciences |
| Address |
EPIP Area,Whitefield,Bangalore -560066 |
| Type of Sponsor |
Other [Trust Hospital] |
|
|
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 Anuja Gopi |
Sri Satya Sai Institute of Higher Medical Sciences |
Department of Radiology, G600, Ground Floor
Sri Sathya Sai Institute of Higher Medical Sciences,
KIADB Export Promotion Industrial Area, Whitefield 560066
Bangalore
KARNATAKA |
08921602741
anujagopi.online@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-Sri Sathya Sai Institute of Higher Medical Sciences ,Whitefield |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G259||Extrapyramidal and movement disorder, unspecified, (2) ICD-10 Condition: G809||Cerebral palsy, unspecified, (3) ICD-10 Condition: G409||Epilepsy, unspecified, (4) ICD-10 Condition: G468||Other vascular syndromes of brainin cerebrovascular diseases, (5) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intramuscular ketamine with dexmedetomidine for pediatric MRI |
In paediatric patients aged 1 to 10 years,a single intramuscular injection with combination of ketamine 3mg/kg with dexmedetomidine 1.5mcg/kg will be given in anterolateral aspect of thigh.Intravenous propofol 0.5mg/kg will be given ,if child awakens during the procedure.Ease of parental seperation,Acceptance of IV cannulation ,additional requirement of propofol for completion of study,hemodynamics,time for discharge and adverse events if any will be observed |
| Comparator Agent |
Intramuscular ketamine with midazolam for paediatric MRI |
In paediatric patients aged 1 to 10 years, a single intramuscular injection with combination of ketamine 3mg/kg with midazolam 0.05mg/kg will be given in the anterolateral aspect of thigh.Intravenous propofol 0.5mg/kg will be given ,if child awakens during the procedure.Ease of parental seperation,Acceptance of IV cannulation ,additional requirement of propofol for completion of study,hemodynamics,time for discharge and adverse events if any will be observed |
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
All patients between the age group of 1 to 10 years belonging to ASA I and II scheduled for elective MRI under sedation will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with active upper respiratory tract infections.
Patients with history of psychiatric illness.
Patients with morbid obesity and syndromic children.
Patients with raised intracranial tension.
Patients with history of known allergy to any of the study drugs, will be excluded from the study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess ease of parental separation
2.To assess acceptance of iv cannulation
3.To assess the requirement of additional supplementation of IV propofol during the procedure. |
Attempt to seperate from parent-Ten minutes after the intramuscular injection.
2.attempt for iv cannulation -one minute after seperating from parent
3.To assess the requirement of additional supplementation of IV propofol:propofol will be given if the child awakens during the mri procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare heart rate, blood pressure, respiratory rate & oxygen saturation in both groups during procedure.
2.To compare the readiness of discharge from recovery room.
3.To compare the incidence of adverse events if any. |
1.Hemodynamics - baseline vitals will be recorded ,5 minute,10 minute,15 minute,20 minute,25 minute,30 minute, 45 minute,60 minute, 75minute, 90 minute,105 minute,120 min
2.Readiness of discharge till child meets the discharge criteria,assessment will be done at 120 minute,150 minute,180 min,210 minute,240 minute,300 minute |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A total of sixty patients aged between one to ten years undergoing elective MRI will be enrolled in the study and will be randomly divided in to two groups DK-dexmedetomidine ketamine and group MK-midazolam ketamine.DK groups will receive intramuscular injection of ketamine 3mg/kg with dexmedetomidine 1.5mcg/kg and group MK will receive intramuscular injection of ketamine 3 mg/kg with midazolam 0.05mg/kg. Injection glycopyrrolate at dose of 5mcg/kg will be given to both groups. Baseline vitals will be recorded. Following this, intramuscular injection at anterolateral aspect of thigh will be given. After ten minutes of injection, attempt will be made to separate the child from the parent and ease of parent separation will be assessed according to scoring scale. Once child is separated, an attempt for securing an intravenous cannula will be done and the ease of securing the cannula will also be given scores according to the scale. After this, child will be taken into the mri suite. pulse rate, oxygen saturation, respiratory rate and blood pressure will be documented every five minutes till the first thirty minutes of procedure followed by documentation every fifteen mins till two hours. If child awakens during the procedure intravenous propofol at a dose of 0.5mg/kg will be given and the total dose will be recorded. Once the procedure is completed child will be transferred to the recovery room and will be observed till the child meets the discharge criteria. Time taken to fulfill the criteria will also be recorded. Parent separation anxiety scale - Patient unafraid, cooperative, asleep=1
- Slight fear or crying, cooperative with reassurance=2
- Moderate fear, crying, not quiet with reassurance=3
- Crying, need for restraint=4
Ease of IV cannulation - No reaction=1
- Minor resistance=2
- Fights without success=3
- Fights with success=4
Discharge criteria - Cardiovascular function and airway patency are satisfactory and stable
- The patient is easily arousable, and protective reflexes are intact
- The patient can talk/phonate (if age appropriate)
- The patient can sit up unaided (if age appropriate)
- For a very young or handicapped child incapable of the usually expected responses, the pre sedation level of responsiveness or a level as close as possible to the normal level for the child should be achieved
- The state of hydration is adequate
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