FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/02/011822 [Registered on: 09/02/2018] Trial Registered Prospectively
Last Modified On: 16/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of a low dose of iv ketamine vs caudal epidural with bupivacaine(Local Anaesthetic) for pain relif in children undergoing surgery under general anesthesia 
Scientific Title of Study   Efficacy of a sub-anesthetic dose of iv ketamine vs caudal epidural with bupivacaine for analgesia in children undergoing inguinoscrotal and lower extremity surgery under general anesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alok Kumar Sahoo 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Science, Bhubaneswar. 
Address  Dept. of Anaesthesiology, AIIMS, Sijua, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884160  
Fax    
Email  alokks108@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alok Kumar Sahoo 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Science, Bhubaneswar. 
Address  Dept. of Anaesthesiology, AIIMS, Sijua, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884160  
Fax    
Email  alokks108@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Alok Kumar Sahoo 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Science, Bhubaneswar. 
Address  Dept. of Anaesthesiology, AIIMS, Sijua, Bhubaneswar
Assistant Professor,Dept. of Anaesthesiology, AIIMS, Sijua, Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  9438884160  
Fax    
Email  alokks108@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Science,Sijua, Bhubaneswar. 
 
Primary Sponsor  
Name  All India Institute of Medical Science Bhubaneswar 
Address  All India Institute of Medical Science,Sijua, Bhubaneswar. 
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 Alok Kumar Sahoo  All India Institute of Medical Science, Bhubaneswar.  AIIMS, Sijua, Bhubaneswar
Khordha
ORISSA 		 9438884160

alokks108@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K40||Inguinal hernia, operative patient, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group -K  will receive a sub-anesthetic dose of ketamine (0.3mg/kg) along with GA 
Comparator Agent  Group C  will be given 1 ml/kg of 0.125% bupivacaine through the caudal route along with GA 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  6.00 Year(s)
Gender  Both 
Details  children below 6yr and above 2 month posted for elective inguinoscrotal or lower limb surgery 
 
ExclusionCriteria 
Details  children with contraindication to caudal anesthesia, or those with cardiovascular diseases, anaemia, known drug allergy to ketamine or bupivacaine, children with clotting disorders, or those whose parents/guardians refuse to provide consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To identify, the efficacy of sub-anesthetic dose of ketamine (0.30 mg/kg) compared to caudal bupivacaine (0.125%, 1ml/kg) for post op analgesia in pediatric patient. The response to pain is defined as FLACC score less than or equal to four immediately after surgery.
The primary outcome of this study is to measure the proportion of patients achieving the response in each group.
 		 post operative 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in inflammatory markers (IL6 and TNF α) between two groups.


- intra operative analgesic requirement
time to extubation,
difference in PONV,
difference in sedation scores,
incidence of emergence delirium

 		 1 yr 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="141" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2018 
Date of Study Completion (India) 01/05/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/05/2020 
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
Modification(s)  		 published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   caudal epidural block has been commonly used in pediatric postoperative pain management in children undergoing lower abdominal surgeries. However, apart from procedural failure, there is the possible risk of accidental dural puncture, infection etc. Moreover, in children with coagulopathy and infection, it is contraindicated.
 Ketamin, an NMDA - receptor antagonist is commonly used in pediatrics, at subanaesthetic IV doses(less than equal to 0.3mg/kg) possesses a centrally mediated analgesic properties, without increasing the risk of side effects seen with normal doses. Numerous clinical studies support the role of subanaesthetic doses of ketamine in acute pain settings. there are also very few studies comparing the efficacy of subanesthetic doses of ketamine vs caudal epidural in pediatrics.
Hence, this study was undertaken to determine the efficacy of subanaesthetic doses of IV ketamine (0.3mg/kg) vs caudal epidural with 1ml /kg of 0.125%bupivacain in children undergoing inguinoscrotal surgeries. 
 
Close