| CTRI Number |
CTRI/2025/10/096032 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Method of prescribing ketamine and midazolam and how safe it is when it is used together in adult burn patients |
|
Scientific Title of Study
|
Prescription pattern and safety of ketamine-midazolam combination in adult burn patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreeya U Shetty |
| Designation |
Student |
| Affiliation |
Manipal College Of Pharmaceutical Sciences |
| Address |
Department Of Pharmacy Practice Manipal College of Pharamceutical Sciences, MAHE, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8151887089 |
| Fax |
|
| Email |
shreeya.shetty@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joseph Thomas |
| Designation |
Professor and Head |
| Affiliation |
Kasturba Medical College |
| Address |
Room 1, Department of Plastic Surgery, Near Infectious Disease Block, Kasturba Medical College, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9995783582 |
| Fax |
|
| Email |
joseph.plastic@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh V |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room 7, Department Of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9538417313 |
| Fax |
|
| Email |
rajesh.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Academy Of Higher Education |
| Address |
Manipal Academy Of Higher Education, Manipal, Karnataka, 576104 |
| Type of Sponsor |
Research institution and 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 Joseph Thomas |
Kasturba Medical College |
Room 1, Department of Plastic Surgery, Near Infectious Disease Block, Katurba Medical College, Manipal, Karnatka
Udupi
KARNATAKA |
9995783582
joseph.plastic@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee -2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X088||Exposure to other specified smoke,fire and flames, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine + Midazolam |
Combination of ketamine and midazolam intended for sedoanalgesia of burn patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients above or equal to 18 years with burn injuries |
|
| ExclusionCriteria |
| Details |
Patients Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assesment of change in pain scores at random time points
|
random points from time of administration to half life ( ketamine half life 2-4 hours, Midazolam half life 1.5-2.5 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Assessment of sedation level
• Requirement for rescue medication
• Presence of ADRs |
random points from time of administration to half life ( ketamine half life 2-4 hours, Midazolam half life 1.5-2.5 hours) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/11/2025 |
| 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="0"
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
|
This study will prospectively evaluate how ketamine–midazolam combination is prescribed and how safe it is in adult burn patients during painful procedures. Patients will receive the drug combination intravenously, and their pain, sedation levels, and side effects will be closely monitored. The findings aim to strengthen pain management strategies and improve overall patient care during treatment of burns. |