| CTRI Number |
CTRI/2025/07/091863 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare Effects Of Ketamine And Midazolam Given As Nasal Drops Before Surgery In Children |
|
Scientific Title of Study
|
A Comparative Evaluation Of Intranasal Ketamine And Intranasal Midazolam For Premedication In Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Pratap Singh |
| Designation |
Junior Resident |
| Affiliation |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
| Address |
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun
Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9897560328 |
| Fax |
|
| Email |
singhpratap50vishal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanika Sachdeva |
| Designation |
Associate Professor |
| Affiliation |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
| Address |
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun
Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9899440374 |
| Fax |
|
| Email |
kanikasachdeva17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Pratap Singh |
| Designation |
Junior Resident |
| Affiliation |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
| Address |
Department Of Anaesthesia Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun
Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9897560328 |
| Fax |
|
| Email |
singhpratap50vishal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun Uttaranchal India PIN Code 248001 |
|
|
Primary Sponsor
|
| Name |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
| Address |
Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun Uttaranchal India PIN code 248001 |
| Type of Sponsor |
Private 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 Vishal Pratap Singh |
Shri Guru Ram Rai Institute Of Medical And Health Sciences |
Department Of Anaesthesia
Shri Guru Ram Rai Institute Of Medical And Health Sciences
Patel Nagar
Dehradun
UTTARANCHAL |
9897560328
pranjal.mamgain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) Shri Guru Ram Rai Institute Of Medical And Health Sciences Patel Nagar Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Ketamine |
Intranasal Ketamine 5 Milligrams Per Kilogram Given Before 10 Minutes Shifting To Operation Theatre |
| Comparator Agent |
Intranasal Midazolam |
Intranasal Midazolam 0.2 Milligrams Per Kilogram Given 10 Minutes Before Shifting To Operation Theatre |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Weight between 10 To 20 Kilogram And ASA Class One |
|
| ExclusionCriteria |
| Details |
Emergency Surgeries And Patients Allergic To Study Drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Parent Separation Score |
Baseline (10 Minutes Before Shifting To Operation Theatre) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mask Acceptance Score |
Immediate Preoperatively |
| Generalised Anxiety Score |
Immediate Preoperatively |
| Vital Parameters |
Perioperative Period Till 24 Hours |
| Drug Related Complications |
Till 24 Hours Postoperatively |
| Ramsay Sedation Score |
Immediate Preoperatively Before Shifting To Operation Theatre to 24 hours Postoperatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 4 |
|
Date of First Enrollment (India)
|
09/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Kanika.mamgain@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-01-2031?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A Comparative Evaluation Of Intranasal Ketamine And Intranasal Midazolam For Premedication In Children Aged Between Three To Eight Years Coming To Shri Guru Ram Rai Institute Of Medical And Health Sciences For Elective Paediatric Surgeries Will Be Conducted And Parent Separation Score Will Be Seen As Primary Outcome. Mask Acceptance Score Generalised Anxiety Score And Ramsay Sedation Score Will Be Evaluated As Secondary Outcome In Seventy Two Patients After Taking Written Informed Consent |