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CTRI Number  CTRI/2024/09/073323 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomized prospective study comparing the efficacy of dexmedetomidine versus midazolam administered through the nasal route for sedation in pediatric patients 
Scientific Title of Study   A randomized prospective study comparing intranasal dexmedetomidine versus intranasal midazolam for sedation in pediatric 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  DR NEETU YADAV 
Designation  PG 2nd year Anaesthesia  
Affiliation  Subharti medical college and hospital  
Address  Subharti Medical College and Hospital, Department of Anaesthesia, Meerut, U.P ,250005
Begam Hazrat Hostel, Subharti University, Meerut, U.P
Meerut
UTTAR PRADESH
250005
India 
Phone  9958421762  
Fax    
Email  neetuyadav445@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NEETU YADAV 
Designation  PG 2nd year Anaesthesia  
Affiliation  Subharti medical college and hospital  
Address  Subharti Medical College and Hospital, Department of Anaesthesia, Meerut, U.P ,250005
Begam Hazrat Hostel, Subharti University, Meerut, U.P
Meerut
UTTAR PRADESH
250005
India 
Phone  9958421762  
Fax    
Email  neetuyadav445@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neetu Yadav 
Designation  PG 2nd year Anaesthesia 
Affiliation  Subharti medical college and hospital  
Address  Subharti Medical College and Hospital, Department of Anaesthesia, Meerut, U.P ,250005
Begam Hazrat Hostel,Subharti university, meerut, U.P
Meerut
UTTAR PRADESH
250005
India 
Phone  9958421762  
Fax    
Email  neetuyadav445@gmail.com  
 
Source of Monetary or Material Support  
Subharti hospital and medical college, Depatment of Anaesthesia, Meerut, U.P, 250005 
 
Primary Sponsor  
Name  SUBHARTI MEDICAL COLLEGE AND HOSPITAL 
Address  SUBHARTI MEDICAL COLLEGE AND HOSPITAL , MEERUT 250001 
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 Neetu Yadav  Subharti hospital and medical college  Subharti Medical College and Hospital, Department of Anaesthesia, Meerut 250005
Meerut
UTTAR PRADESH 
09958421762

neetuyadav445@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee ( Medical )  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine   Before entering into any procedure room, intranasal dexmedetomidine will be given intranasally using 2ml syringe in recumbent position at a dose 2mcg/kg. Sedation score is assesed by using Ramsay sedation score and Observers assessment of alertness/ sedation score till 40min or before till sedation being achieved.  
Intervention  Midazolam  Before entering into any procedure room, intranasal midazolam is given at a dose 0.5mg/kg using the intranasal spray with the child in recumbent position and sedation to be observed using Ramsay sedation score and Observers assessment of alertness/sedation score till 40mins or before till sedation achieved. 
Comparator Agent  Sedation  Sedation is being assessed by using Ramsay sedation score and Observers assessment of alertness/sedation score for 40 mins or beforehand till sedation is being achieved by comparing intranasal dexmedetomidine and intranasal midazolam.  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 ASA CLASS I & II
2 Age from 1-12yrs.
3 Patients of either sex. 
 
ExclusionCriteria 
Details  1 Children with an allergy to the study drug.
2 Children with organ dysfunction.
3 Children with any congenital heart disease.
4. Refusal by the parents. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of intranasal dexmedetomidine and intranasal midazolam in pediatric patient for sedation.   40mins 
 
Secondary Outcome  
Outcome  TimePoints 
1 To compare hemodynamic changes in both the groups.
2 To compare side effects in both the groups, if any.  
40 MINS. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   19/09/2024 
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="0"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 19-08-2024 and end date provided 09-10-2028?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Prior to any operative procedure, children are often susceptible to fear & anxiety of being separated from parents & entering the operating room environment. Premedication plays an important role in allowing a smooth separation of the child from the parent. One of the ways, an anaesthesiologist can deal with this challenge is to sedate the child beforehand. Children tolerate oral and nasal route better than intravenous route for needle fear. Preoperative anxiety during any procedure in children is a major concern, approximately 60% of pediatric patients suffer preoperative anxiety. Children may become overtly uncooperative at the time of separation from parents.

Nasal premedication with midazolam and dexmedetomidine has been studied as alternatives to oral premedication and injectables with comparable results. Intranasal route is a non-invasive route well tolerated by the pediatric patient . Bioavailability is highly primarily due to rich vasculature in the nasal mucosa. Onset of action is quicker than other systemic routes. Drugs administered via the nasal route are rapidly absorbed into the systemic circulation because they do not pass through portal circulation.

Dexmedetomidine is a newer alpha 2 agonist with mopre selective alpha 2 : alpha 1 adrenoreceptor activity with a short half life. Since this drug has a neutral pH, it is virtually painless when given given intanasally and it is also tasteless and odourless. Recently, it has been recommended for procedural sedation in children. In addition to its sedative property, dexmedetomidine exerts analgesics and antiemetic effects. In comparison with other ana;lgesics and sedative agents, dexmedetomidine has minimal effects on respiration.

Midazolam is one of the most commonly used sedative premedication in pediatric anaesthesia. It is employed in a variety of surgical and non surgical procedures. Midazolam is water soluble benzodiazepine that works by inhibiting the GABA receptor. It has sedative and anxiolytic properties, which makes easier to perform any procedure. As midazolam has high hepatic clearance , avoidance of first pass metabolism offers greater systemic bioavailabilty. The beneficial effect of modazolam includes rapid sedation, anxiolytic and reduction of post operative nausea and vomiting. However, the major drawback is that atleast 50% children cry on administration because it transiently irritates nasal passage.
 
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