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CTRI Number  CTRI/2024/07/071230 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparative study between two routes of Midazolam administeration for sedation in children. 
Scientific Title of Study   Comparison between oral midazolam and intranasal midazolam for sedative premedication in paediatric 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  Reem Khatib 
Designation  MD Anaesthesiology Resident  
Affiliation  Dr D Y Patil Medical College, Hospital and Research Centre 
Address  5th floor, hi tech building, Department of Anaesthesia, Dr D Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  07798814393  
Fax    
Email  reem.bk26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shahbaz Hasnain 
Designation  Cardiac Anaesthesiologist 
Affiliation  Dr D Y Patil Medical College, Hospital and Research Centre 
Address  5th floor, hi tech building, Department of Anaesthesia, Dr D Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  9764621253  
Fax    
Email  shahbazhsnn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Reem Khatib 
Designation  MD Anaesthesiology Resident  
Affiliation  Dr D Y Patil Medical College, Hospital and Research Centre 
Address  5th floor, hi tech building, Department of Anaesthesia, Dr D Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune 411018

Pune
MAHARASHTRA
411018
India 
Phone  07798814393  
Fax    
Email  reem.bk26@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune, India, 411018  
 
Primary Sponsor  
Name  Dr Reem Khatib 
Address  5th floor, hi tech building, Department of Anaesthesia, Dr D Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune 411018 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reem Khatib   Dr D Y Patil Hospital , Pimpri-411018  OT complex, 5th floor, hi tech building, Department of Anaesthesiology
Pune
MAHARASHTRA 		 7798814393

reem.bk26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Recognition   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intranasal Midazolam Spray and Oral Midazolam   Intranasal Midazolam Spray and Oral Midazolam  
Intervention  Intranasal Midazolam Spray and Oral Midazolam  Intranasal Midazolam Spray(0.1mL or 0.5mg per spray , 0.2mg/kg) and Oral Midazolam (5mg per mL ampoule, 0.5mg/kg) each for a total duration of 20 minutes after administration  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1-5 years aged patients of either sex
ASA I – II
Patients posted for routine paediatric surgeries
Hemodynamically stable patients with all routine investigations within normal limits.
Patients whose parents or guardians give written informed consent and are willing their child to be a part of the study. 
 
ExclusionCriteria 
Details  6 years and above
ASA grade 3 and above
known allergy to study drugs
nasal pathology 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.  Five point sedation score followed by parental separation score will be assessed at the end of 20 minutes from administeration of the drug. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.  Acceptance to mask & response to venepuncture will be assessed after 20 minutes of drug administer in the operating room
The Modified Alderte score shall be assessed for 30 minutes from extubation in the recovery room 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   05/08/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [reem.bk26@gmail.com].

  6. For how long will this data be available start date provided 07-11-2025 and end date provided 04-10-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   It is a randomized, prospective, clinical, double blind comparative study to assess the effectiveness of preoperative oral midazolam with intranasal midazolam for sedative premedication in paediatric patients for degree of sedation, ease of parental separation, response to venepuncture, acceptance to mask and post operative recovery. 
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