| CTRI Number |
CTRI/2025/07/091128 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, ketamine and midazolam as pre medicant in pediatric patient undergoing elective surgery |
|
Scientific Title of Study
|
A study comparing nebulised ketamine and midazolam as pre medicant in pediatric patient undergoing elective surgery |
| 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 Sanjay Johar |
| Designation |
Professor |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and critical care
Pt BD Sharma
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416050652 |
| Fax |
|
| Email |
sanjays321@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Sukhija |
| Designation |
junior resident |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and critical care Pt BD Sharma PGIMS Rohtak Haryana
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9728776410 |
| Fax |
|
| Email |
mansisukhija261097@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Sukhija |
| Designation |
Junior resident |
| Affiliation |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and critical care Pt BD Sharma PGIMS Rohtak Haryana
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9728776410 |
| Fax |
|
| Email |
mansisukhija261097@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, Pt BD Sharma Rohtak Haryana 124001
India |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and critical care
PGIMS Rohtak Haryana 124001 INDIA |
| 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 Sanjay Johar |
Pt BD Sharma PGIMS Rohtak |
Department of anesthesiology and critical care Pt BD Sharma PGIMS Rohtak Haryana 124001 India
Rohtak
HARYANA |
9416050652
sanjays321@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee, Pt BD Sharma PGIMS/UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ketamine
|
ketamine(2mg/kg) diluted to final volume of 3mL of solution using 0.9% normal saline, nebulized to pediatric patients for 15 minutes before transfer to operating room and assesing for Ramsay sedation score, separation score, face mask acceptance score and vitals at interval of 5 mins for 30 mins |
| Comparator Agent |
midazolam |
Midazolam(0.2mg/kg) diluted to final volume of 3ml of solution using 0.9% normal saline, nebulized to pediatric patients for 15 mins before tranfer to operating room and assessing for Ramsay sedation score, separation score, facemask acceptance score and vitals at interval of 5mins for 30mins |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I & II scheduled to undergo various elective surgical procedures |
|
| ExclusionCriteria |
| Details |
1. children with history of developmental delay
2. children with systemic illness like - cardiac
diseases, neurological, liver and renal disease.
3.parents refusing to give consent.
4. known allergy or hypersensitivity to ketamine or midazolam |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of level of sedation and effectiveness of nebulised ketamine and midazolam as premedicant |
From the time of administration of drug at every 5 mins interval for first 30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare time of onset of action, ease of child-parent separation, ease of induction in operative room, and effect of two drugs on intra-operative hemodynamics |
From the time of administration of drug at every 5 mins interval for first 30 mins |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="8"
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
|
The present prospective study will be conducted in the department of anesthesia and critical care, PGIMS Rohtak. Written informed consent will be taken from patients included. Then comparison of effectiveness of nebulised ketamine and midazolam as pre medicants. Data will be compiled and analysed with appropriate statistical test. |