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CTRI Number  CTRI/2024/11/077125 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 10/01/2026
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   Ketodex (Ketamine+dexmedetomidine) versus midazolam as nasal spray for sedation in children undergoing spine surgery  
Scientific Title of Study   Comparison of the efficacy of Intranasal Atomised Ketodex versus Intranasal Atomised Midazolam as a Premedicant for anxiolysis and sedation in children aged 1 to 10 years undergoing spinal dysraphism surgery- A randomized double-blinded controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
INT/IEC/2024/SPL-1169  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankur Luthra 
Designation  Associate Professor 
Affiliation  Postgraduate institute of Medical Education and Research, Chandigarh 
Address  Room No. 1, B-Block, 5th floor, Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9868057732  
Fax    
Email  zazzydude979@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankur Luthra 
Designation  Associate Professor 
Affiliation  Postgraduate institute of Medical Education and Research, Chandigarh 
Address  Room No. 1, B-Block, Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9868057732  
Fax    
Email  zazzydude979@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shruti Bhatt 
Designation  Junior Resident 
Affiliation  Postgraduate institute of Medical Education and Research, Chandigarh 
Address  Nehru Hospital, 4th floor, Block A, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7251812716  
Fax    
Email  shruti12bhatt@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh 
 
Primary Sponsor  
Name  Ankur Luthra 
Address  Department of Anaesthesia and intensive Care, Nehru Hospital, PGIMER, Sector 12, Chandigarh - 160012  
Type of Sponsor  Other [Self] 
 
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 Ankur Luthra  PGIMER Chandigarh  Main OT complex,Department of Anaesthesia and Intensive care, 4th Floor, A-Block, Nehru Hospital Chandigarh CHANDIGARH
Chandigarh
CHANDIGARH 
9868057732

zazzydude979@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER Ethics Committee  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  Patients will be receiving Intranasal atomised ketodex (Ketamine 3mg/kg + Dexmed 1 mics/kg) 30 minutes before induction.   A calculated dose of ketamine 3 mg/kg and 1 mics/kg dexmedetomidine will be diluted to 2 ml with 0.9% normal saline and taken in a 2 ml syringe and 0.1 ml extra volume will be taken for dead space of atomiser. Half of this dose will be administered in one nostril and other half in the other nostril in upward and outward direction with child in supine position 30 minutes before induction once only.  
Comparator Agent  Patients will be receiving Intranasal atomised midazolam (0.4 mg/kg) 30 minutes before induction.  The calculated dose of 0.4 mg/kg midazolam will be diluted to 2 ml with 0.9% normal saline and taken in a 2 ml syringe and 0.1 ml extra volume will be added for dead space of atomiser. Half of the dose will be administered in one nostril and the other half in the other nostril in an upward and outward direction with the child in the supine position 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  70 ASA I and II children aged between 1-10 years who were scheduled for spinal dysraphism surgery will be enrolled in this study. 
 
ExclusionCriteria 
Details  Refusal of consent
Known allergy to dexmedetomidine or ketamine
ASA III or IV
Children with cardiac anomalies
Children with seizures
Children with upper respiratory tract infection
Children with liver disease
Children with mental retardation
Difficult cannulation (three or more attempts)  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of the effectiveness of sedation between intranasal atomised ketodex versus midazolam in children aged 1 to 10 years undergoing spinal dysraphism surgery by University of Michigan Sedation Scale (UMSS).   30 minutes after drug administration 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the response to parental separation assessed by Parental Separation Anxiety Score (PSAS)  30 min after drug administration 
To compare the successful rate of venous canulation assessed by the Groningen Distress Rating Score (GDRS)   30 min after drug administration 
To compare mask acceptance assessed by the Mask Acceptance Scale (MAS)   30 min after drug administration 
To compare the hemodynamic changes (HR, MAP, SpO2)  35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 65 min, 70 min, 75 min, 80 min, 85 min and 90 min after drug administration  
To compare the incidence of Emergence agitation assessed by using the WATCHA Scale   At the end of surgery and anaesthesia 
To compare the time for post operative discharge from Post Anaesthesia Care Unit (PACU) by Modified Aldrete Scoring   At the end of PACU stay  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   17/11/2025 
Date of Study Completion (India) 30/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/11/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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  

Preoperative anxiety can occur in as much as 80% of surgical patients.11 Two vulnerable groups of patients are females and children. While most female adults are usually concerned about the uncertainty of their future, their family, the success of the operation, and the safety of anaesthesia, the children, by contrast, will experience varying degrees of separation anxiety before an operation. Both psychological and pharmacological approaches are effective in decreasing preoperative anxiety. A child’s preoperative anxiety can pose a significant challenge for the anaesthetic team and can be distressing for parents. Evidence suggests that preoperative anxiety is associated with adverse outcomes, both clinical (increased requirements for analgesics and emergence delirium) and behavioural (sleep disturbances and enuresis)12 Various drugs have been used as premedication to allay anxiety and facilitate the smooth separation of the child from parents such as midazolam, ketamine, dexmedetomidine, clonidine, melatonin and sufentanil.1 The ideal premedicant should be readily acceptable and should have a rapid onset of action, reliable effect and faster recovery from the sedative effect of the drug. Since there is a discrepancy in the results of various studies on the superiority of the atomised form of one drug given intranasally over another and there is no study comparing the effectiveness of intranasal atomised ketodex versus midazolam for premedication in children aged 1 to 10 years of age. Therefore, we would like to compare the effectiveness of intranasal atomised ketodex using dexmedetomidine at a dose of 1 μg/kg and ketamine at a dose of 3 mg/kg with intranasal atomised midazolam 0.4 mg/kg in children aged 1 to 10 years for premedication undergoing spinal dysraphism surgery and we hypothesize that intranasal atomized ketodex will be non-inferior to intranasal midazolam as a premedicant for anxiolysis and sedation in children aged 1-10 years undergoing spinal dysraphism surgery.

 
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