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CTRI Number  CTRI/2022/04/042249 [Registered on: 28/04/2022] Trial Registered Prospectively
Last Modified On: 06/07/2023
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   Dexmedetomidine versus ketamine by administration as nasal spray for sedation in children undergoing spine surgery 
Scientific Title of Study   Comparison of the efficacy of Intranasal Atomised Dexmedetomidine versus Intranasal Atomised ketamine as a premedicant for anxiolysis and sedation in paediatric population aged 1-10 years undergoing spinal dysraphism surgery - a randomised double blinded controlled trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC-INT/2022/MD-87 12/4/22  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  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  PGIMER, Sector 12, Chandigarh


CHANDIGARH
160012
India 
Phone  9868057732  
Fax    
Email  zazzydude979@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chethan Hebbar K 
Designation  Junior Resident 
Affiliation  Postgraduate institute of medical Education and research, Chandigarh 
Address  Nehru Hospital, 4th Floor, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7259299687  
Fax    
Email  kchebbar5005@gmail.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 
Ankur Luthra  PGIMER Chandigarh  Main OT Complex, Department of Anaesthesia and Intensive care, 4th Floor, A-Block, Nehru Hospital
Chandigarh
CHANDIGARH 		 9868057732

zazzydude979@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER  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 
Comparator Agent  Patients will receive intranasal atomised ketamine 5mg/kg 30minutes before induction.  Calculated dose of 5mg/kg ketamine will be diluted to 2ml with 0.9% normal saline and taken in 2ml syringe and 0.1ml extra volume will be added for dead space of atomiser. Half of the dose will be administered in one nostril and other half in the other nostril in upward and outward direction with child in supine position. 
Intervention  Patients will receive single dose of intranasal atomised dexmedetomidine 2.5μg/kg 30minutes before induction.  Calculated single dose of 2.5ug/kg dexmedetomidine will be diluted to 2ml with 0.9% normal saline and taken in 2ml syringe and 0.1ml extra volume will be taken for dead space of atomiser.Half of the 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 taking the patient to OT. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  64 ASA I and II children aged between 1-10years 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 
To compare the effectiveness of sedation between intranasal atomised dexmedetomidine versus intranasal atomised ketamine in pediatric population aged 1-10yr undergoing spinal dysraphism surgery by using University of Michigan Sedation Scale (UMSS).  At 30 minutes post drug administration via intranasal route.  
 
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 Groningen Distress Rating Score  30 min after drug administration 
To compare mask acceptance assessed by Mask Acceptance Scale  30 min after drug administration 
To compare the hemodynamic changes (HR, MAP, SpO2) intraoperatively  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 incidence of Emergence agitation assessed by using WATCHA Scale  At the end of surgery 
To compare the time for post operative discharge from PACU by Modified Aldrete Scoring  At the end of PACU stay 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/05/2022 
Date of Study Completion (India) 14/12/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/12/2022 
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   No similar publications in the past 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The Perioperative period can be veery traumatic time for young children undergoing any form of surgery. Anaesthesiologists strive to m minimise distress for children in the operating room and provide smooth induction of anaesthesia. Various premedications have been used to allay anxiety and facilitate smooth separation of children from their parents. Intranasal administration is easy and safe and reduces discomfort. Drugs like dexmedetomidine, ketamine, midazolam and fentanyl have been tried for sedation and anxiolysis. Atomisation of drug refers to making an aerosol, which gets better absorbed through the nasal mucosa and provides quite effective sedation. Since, there is discrepancy in the results of various studies on the superiority of one drug over the other via intranasal route by drops and there is no study comparing effectiveness of intranasal atomised dexmedetomidine versus ketamine for premedication in children, we hypothesised that intranasal atomised dexmedetomidine is equally effective to intranasal atomised ketamine as premedicant for anxiolytics and sedation in children of 1-10 years undergoing spinal dysraphism surgery.  
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