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CTRI Number  CTRI/2022/02/040166 [Registered on: 10/02/2022] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on caudal dexmedetomidine and intravenous dexmedetomidine in children for reducing pain after surgery 
Scientific Title of Study   Comparison of caudal bupivacaine and dexmedetomidine with caudal bupivacaine and intravenous dexmedetomidine for post operative analgesia in children. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kuldeep Singh 
Designation  PG student 
Affiliation  VMMC and Safdarjung Hospital 
Address  Room no 6 ,OT Block Department of Anaesthesiology VMMC and Safdarjung Hospital Delhi
South Delhi,Delhi
New Delhi
DELHI
110029
India 
Phone  8368510372  
Fax    
Email  cariappan.tiger.10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jeetendra Kumar Bajaj 
Designation  Consultant Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Room no 6 , Ground floor OT Block Department of Anaesthesiology VMMC and Safdarjung Hospital Delhi
South Delhi .Delhi
New Delhi
DELHI
110029
India 
Phone  9810465070  
Fax    
Email  jeetendrabajaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jeetendra Kumar Bajaj 
Designation  Consultant Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Room no 6 ,Ground floor OT Block Department of Anaesthesiology VMMC and Safdarjung Hospital Delhi
South Delhi .Delhi
South
DELHI
110029
India 
Phone  9810465070  
Fax    
Email  jeetendrabajaj@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung Hospital, New Delhi 
 
Primary Sponsor  
Name  Department of Anaesthesia and intensive care VMMC and Safdarjung Hospital 
Address  South delhi ,Delhi. 110029  
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 
Kuldeep Singh  VMMC and Safdarjung Hospital  Room no 6 ground floor OT Block Department of Anaesthesiology and critical care
South
DELHI 		 8368510372

cariappan.tiger.10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC VMMC and Safdarjung Hospital  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 through caudal route  patients of group A will be given 1ml per kg of 0.25% bupivacaine with 1 mcg per kg dexmedetomidine through caudal route and will be monitored for 24 hrs at 1hr 2hr 4hr 8hr 12hr 24hr . 
Comparator Agent  Dexmedetomidine through intravenous route  patients of group B will be given 1ml per kg of 0.25% bupivacaine caudal route and 1mcg per kg dexmedetomidine through intravenous route over 10min and will be monitored for 24hrs at 1hr 2hr 4hr 8hr 12hr 24hr. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  American society of Anaesthesiologists physical status I-II
Age 1 to 8 year old children.
Scheduled for elective surgery. 
 
ExclusionCriteria 
Details  Infection at the site of block.
Coagulopathy.
Pre-existing neurological or spinal disease and abnormalities of the sacrum.
Allergy to local anaesthetics. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare caudal and intravenous dexmedetomidine for prolongation of post operative analgesia in children undergoing elective surgeries using FLACC scale  Measuring post operative analgesia using FLACC score and Ramsay sedation score at 1 2 4 8 12 24hrs after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the intra operative haemodynamic effects and sedation with dexmedetomidine given through caudal or intravenous route  Monitoring baseline HR BP SPO2 preoperatively
Monitoring HR BP SPO2 intraoperatively every 5min
Monitoring HR BP SPO2 post operatively and follow up for next 1hr 2hr 4hr 8hr 12hr 24hr 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   11/02/2022 
Date of Study Completion (India) 30/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is randomized participant blinded  parallel group study comparing two groups of  48 children each undergoing elective surgeries. One group  is  given  caudal bupivacaine  and  caudal dexmedetomidine  and other group is given caudal bupivacaine and intravenous dexmedetomidine  .The study will be conducted in VMMC and Safdarjung Hospital,New Delhi . The primary objective of the study is post operative analgesia in children undergoing elective surgeries  using FLACC scale and secondary objective  of the study is intraoperative  haemodynamic effects and sedation with dexmedetomidine given through caudal or intravenous route. 
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