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CTRI Number  CTRI/2024/01/061537 [Registered on: 16/01/2024] Trial Registered Prospectively
Last Modified On: 08/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of dexamethasone as an additive to bupivacaine for pain relief in children 
Scientific Title of Study   Effect of dexamethasone as an adjuvant on analgesic efficacy of bupivacaine in caudal block in pediatric infraumbilical surgeries 
Trial Acronym  Not applicable  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varun G K 
Designation  Postgraduate resident in anaesthesiology  
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  8151023223  
Fax    
Email  varungkaranam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shakuntala J Goswami 
Designation  Professor(H.G) 
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9327021192  
Fax    
Email  dhrumit09@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shakuntala J Goswami 
Designation  Professor(H.G) 
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9327021192  
Fax    
Email  dhrumit09@yahoo.com  
 
Source of Monetary or Material Support  
B.J.Medical College and Civil Hospital , Government of Gujurat 
 
Primary Sponsor  
Name  Government of Gujurat 
Address  7 th floor, Health and family welfare department , Sachivalay, Gandhinagar 
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 Varun G K  B.J.Medical College and Civil Hospital , Ahmedabad  Department of anaesthesia, Room number O3 , third floor, Pediatric surgery operation theatre, 1200 bed hospital, Asarwa, Ahmedabad 380016
Ahmadabad
GUJARAT 		 8151023223

varungkaranam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee , B.J.Medical College and Civil Hiospital , Ahmedabad  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  Single shot caudal anaesthesia Bupivacaine(0.25%) 2mg/kg with volume of 1 ml/kg + Dexamethasone 1ml (0.1mg/ kg) as dosage for caudal block  Dexamethasone is added as an adjuvant to study the effectiveness in post operative pain relief  
Comparator Agent  Single shot caudal anaesthesia Bupivacaine(0.25%)2mg/kg with volume of 1 ml/kg + 1ml NS as dosage for caudal block  Bupivacaine with no adjuvant in studying effectiveness in Post operative pain relief  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  ASA I II III
Consent from legally authorized representative
Infraumbilical surgeries  
 
ExclusionCriteria 
Details  ASA IV V
Refusing to give consent
Patient with pre existing cardiac, neurological and respiratory diseases
Patients having coagulopathy
Patient with congenital spine anomaly
local infection 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To study postoperative pain relief in both groups
 		 Pain profile is measured in terms of FLACC scale 24 hours post operatively every 15 minutes for 1 hr and every half hour for next 4 hours and hourly till 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To compare postoperative complication in both groups.
Intraoperative hemodynamic parameters in both groups 		 24 hours post operativve 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   21/01/2024 
Date of Study Completion (India) 31/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Pain is unpleasant experience which can produce changes in all system of the body. Anticipation and effective treatment of pain in pediatric patient is thus essential component of care. The under treatment of acute post operative pain in children leads to activation of physiological and biochemical stress leading to impaired metabolic, neurological, endocrine, pulmonary and immunological function. Single shot caudal is preferred and most commonly used technique. However it has short duration of action after single injection. Prolongation of single caudal block has been achieved by addition of various adjuvants like ketamine, opioids to local anaesthetics providing post operative analgesia. This study is designed to compare the effect of the quality of pain relief between caudal bupivacaine versus caudal dexamethasone with bupivacaine in pediatric infraumbilica 
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