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CTRI Number  CTRI/2025/08/093790 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of dexamethasone and fentanyl as additives to levobupivacaine for pain relief and early motor function recovery after caudal anaesthesia in paediatric patients undergoing surgery 
Scientific Title of Study   Efficacy of dexamethasone versus fentanyl in addition to levobupivacaine in caudal anaesthesia in paediatric postop patients: A randomized controlled trial. 
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 Rakshit Maheshwari 
Designation  Post Graduate Trainee 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  7976542556  
Fax    
Email  greeneyescool@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Supriya Kar 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  8895509370  
Fax    
Email  supriya.kar@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Supriya Kar 
Designation  Assistant Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar


ORISSA
751024
India 
Phone  8895509370  
Fax    
Email  supriya.kar@kims.ac.in  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha, India 751024 
 
Primary Sponsor  
Name  Dr Rakshit Maheshwari 
Address  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, KIIT deemed to be university, Bhubaneswar 
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 Rakshit Maheshwari  Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences  Department of Anaesthesiology, Kalinga Institute of Medical Sciences, Bhubaneswar, 751024
Khordha
ORISSA 		 7976542556

greeneyescool@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES  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  Efficacy of dexamethasone versus fentanyl in addition to levobupivacaine in caudal anaesthesia in paediatric postop patients: A randomized controlled trial.  Group A- will receive 0.125% levobupivacaine (1 ml/kg) and dexamethsone (0.1 mg/kg)  
Intervention  Efficacy of dexamethasone versus fentanyl in addition to levobupivacaine in caudal anaesthesia in paediatric postop patients: A randomized controlled trial.  Group B- will receive 0.125% levobupivacaine (1 ml/kg) and fentanyl (1 mcg/kg) 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1)American society of anaesthesiologist(ASA) physical status I and II
2)In infraumibilical surgeries posted for general anaesthesia with caudal block
3)Duration of surgery less than 120 minutes
4)Post anaesthesia care unit(PACU) stay less than 60 minutes 
 
ExclusionCriteria 
Details  1)Coagulopathies
2)Allergy to study drugs
3)Spinal deformities
4)Procedural failure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time of administration of first rescue analgesia (Inj PCM 15 mg/kg)  24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Motor function recovery postoperatively in PACU using modified bromage scale  1 hour 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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   Phase 2 
Date of First Enrollment (India)   01/10/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   Caudal block is safe, effective and reliable analgesic technique widely recommended in paediatric surgeries.
Caudal block with only local anaesthesia offers superior short term analgesia. As a result, different adjuncts like dexamethasone, fentanyl, ketamine, morphine are used to prolong the analgesic effect.
We hypothesize that there is no significant difference in the efficacy of dexamethasone and fentanyl as an adjunct to local anaesthesia (levobupivacaine) in caudal block for postoperative analgesia and early motor function recovery. 
 
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