| CTRI Number |
CTRI/2021/05/033895 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of efficiency of ketamine when injected into a blood vessel or injected in a muscle for providing a sleep state for children to undergo MRI scan. |
|
Scientific Title of Study
|
Comparison between intravenous ketamine and intramuscular ketamine sedation for Magnetic Resonance Imaging in pediatric patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuj Jain |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Anaesthesia
All India Institute of Medical Sciences Bhopal
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9755702644 |
| Fax |
|
| Email |
anuj.jain.mln@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuj Jain |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Anaesthesia
All India Institute of Medical Sciences Bhopal
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9755702644 |
| Fax |
|
| Email |
anuj.jain.mln@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuj Jain |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Anaesthesia
All India Institute of Medical Sciences Bhopal
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9755702644 |
| Fax |
|
| Email |
anuj.jain.mln@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhopal |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Observing the usual protocol followed for sedation, in usual protocol anaesthesia is free of cost] |
|
|
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 Anuj Jain |
All India Institute of Medical Sciences Bhopal |
Department of Anaesthesia,
In front of AB3 ICU,
Third floor,
Hospital building.
Bhopal
MADHYA PRADESH |
9755702644
anuj.jain.mln@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Bhopal Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z138||Encounter for screening for otherspecified diseases and disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender of age group 2 to 8 year.
American society of anaesthesiologists physical status (ASA) I and II patients. |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult airway.
Raised Intracranial or intraocular pressure.
Vascular aneurysms.
History of adverse reaction to ketamine or any other drug used in the study
Active seizures. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intravascular and Intramuscular route of ketamine administration are almost equally popular in MRI sedation. However, the use of ketamine in sedation for MRI is highly skewed in favour of intravascular. The two routes have never been compared for sedation in MRI.
The sedative efficacy and safety profile and time to discharge in intravenous and intramuscular ketamine are not significantly different. IM method might lead to lesser need of rescue doses. |
0-6th month – Collection of data and literature review.
6th -7th – statistical calculations will be done and result will be provided. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare any adverse events like bradycardia, hypotension, desaturation, laryngospasm, apnea, excessive salivation, vomiting, emergence delirium, excessive drowsiness, involuntary movements, seizure occurring during the MRI scanning or in the recovery period.
To compare the time required for recovery to achieve Modified Andree score equal to 9 or more. |
0-6th month – Collection of data and literature review.
6th -7th – statistical calculations will be done and result will be provided. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
01/06/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pediatric patients coming for MRI scan for various complaints who fullfil the inclusion criteria will be enrolled for study. Intravenous and intramuscular route for giving ketamine sedation is equally used in our institute. 108 patients will be enrolled. 54 in each group. The assignment of the patient to the IV or IM ketamine group will depend on the personal preference of the anaesthesiologist faculty incharge on that day. The doses of ketamine is 1 mg/kg and 4 mg/kg in IV and IM group respectively. In case of inadequate sedation within 10 mins half of loading dose of ketamine will be repeated. Patients will undergo MRI scan after adequately sedated. Rescue doses of propofol 0.5mg/kg will be used in case of inadequate sedation during the scan. Sedation efficacy of IV and IM will be assesed based on the time required to achieve adequate sedation to start MRI scan, number of rescue doses of propofol required to complete the scan and number of MRI sequences repeated due to inadequate sedation. Patients will be monitored for any adverse events during and after scan. Recovery time will be monitored using Modified Aldrete score of equal to or more than 9. |