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CTRI Number  CTRI/2025/10/095769 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study to evaluate the efficacy of intranasal dexmedetomidine versus intranasal midazolam as premedication in pediatric age group. 
Scientific Title of Study   Comparative study to evaluate the efficacy of intranasal dexmedetomidine versus intranasal midazolam as premedication in pediatric age group. 
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 Salma Sultana 
Designation  Secondary dnb resident  
Affiliation  Hindu Rao Hospital 
Address  A-18 Malka Ganj

North
DELHI
110007
India 
Phone  9836169477  
Fax    
Email  drsalma989@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Salma Sultana 
Designation  Secondary dnb resident  
Affiliation  Hindu Rao Hospital 
Address  A-18 Malka Ganj

North
DELHI
110007
India 
Phone  919836169477  
Fax    
Email  drsalma989@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Salma Sultana 
Designation  Secondary dnb resident  
Affiliation  Hindu Rao Hospital 
Address  A-18 Malka Ganj

North
DELHI
110007
India 
Phone  9836169477  
Fax    
Email  drsalma989@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  North DMC medical college and Hindu Rao Hospital  
Address  Gandhi Square Malka Ganj Delhi 110007 
Type of Sponsor  Government 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 Salma Sultana   North DMC Medical College and Hindu Rao Hospitall  Gandhi square Malka Ganj Department of Anaesthesia 110007
North
DELHI 
9836169477

drsalma989@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee North DMC Medical College And Hindu Rao Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine and Midazolam   Intranasal instillation 1.5 ug/kg and 0.1mg/kg 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients between 1 Yr to 12 yrs
Patients weight between 7.5kgs -45kgs
Patients belonging to ASA grade I & II
Patients undergoing elective procedure under general anaesthesia  
 
ExclusionCriteria 
Details  Patients refusing to participate
Patients with risk of pulmonary aspiration
Patients with history of difficult intubation
MM score 3&4
Patients with reactive airway and spine deformity
Patients with history of cardiac,respiratory, renal or hepatic disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To assess all patients for ease of sedation using Ramsay 6 point sedation score  To assess all patients for ease of sedation using Ramsay 6 point sedation score 
 
Secondary Outcome  
Outcome  TimePoints 
Assess secondary parameters such as blood pressure heart rate & oxygen saturation
Assess child parents separation score
Mask acceptance score
Any adverse reactions 
30 minutes after premedication  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/11/2025 
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  
The intra nasal administration of midazolam has shown to be very effective,easy,a non-invasive route with better acceptance, higher safety,rapid onset of  action with higher bioavailability due to the  vascularization of nasal mucosa and bypassing hepatic metabolism.
Dexmedetomidine (DEX) is a highly selective, short- acting, alpha 2-adrenoreceptor agonist used for conscious sedation, and analgesia perioperatively.
It provides sedation, anxiolysis, and analgesic effects without causing respiratory depression.
Dexmedetomidine has been extensively investigated in the pediatric population with increasing evidence supporting its use, including as premedication.
The sedative property is  thought to be due to G-proteins activation by the presence of alpha 2a receptors in the brainstem resulting in inhibition of norepinephrine release, with a short half-life and having a bioavailability of around (72.6–92.1%) when administered via the intranasal route.
The intranasal mode of administration of dexmedetomidine has advantage over the intravenous mode in respect to ease of administration,higher bioavailability  with minimal discomfort, provide sedation without respiratory depression, reduce emergence delirium and postoperative negative behaviour such as aggression.
This study evaluates the efficacy of intranasal administered dexmedetomidine (Dose- 1.5 ug/kg ) compared to intranasal midazolam (0.1mg/kg) in pediatrics age group as per-medication.
 
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