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CTRI Number  CTRI/2024/01/061191 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 02/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of dexmedetomidine and clonidine in caudal block in paediatric patients posted for infra umbilical surgeries. 
Scientific Title of Study   Comparative study to evaluate efficacy and safety of dexmeditomidine and clonidine as adjuvant with bupivacaine for caudal block in pediatric patients posted for infra umbilical surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubham Rahane 
Designation  Junior Resident 
Affiliation  Acharya Vinobha Bhave Rural Hospital, JMNC 
Address  AVBRH, JNMC, Wardha, Maharashtra, 442001
AVBRH, JNMC, Sawangi (Meghe), Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India 
Phone  9359691943  
Fax    
Email  shubhamrahane7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeta Chaudhary Verma 
Designation  Professor, Department of Anaesthesiology, JNMC 
Affiliation  Acharya Vinobha Bhave Rural Hospital, JNMC 
Address  Department of Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India 442001
AVBRH, JNMC, Sawangi (Meghe), Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India 
Phone  9423421689  
Fax    
Email  neetachaudhary123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubham Rahane 
Designation  Junior Resident 
Affiliation  Acharya Vinobha Bhave Rural Hospital, JMNC 
Address  AVBRH, JNMC, Wardha, Maharashtra, India 442002
AVBRH, JNMC, Sawangi (Meghe), Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India 
Phone  9359691943  
Fax    
Email  shubhamrahane7@gmail.com  
 
Source of Monetary or Material Support  
Acharya Vinobha Bhave Rural Hospital, JNMC, Sawangi (Meghe), Wardha, Maharashtra 442001 
 
Primary Sponsor  
Name  Acharya Vinobha Bhave Rural Hospital 
Address  Sawangi (Meghe), Wardha, Maharashtra, India 442001 
Type of Sponsor  Private 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 Shubham Rahane  Acharya Vinobha Bhave Rural Hospital  Department of Anaesthesiology, JNMC, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India, 442001
Wardha
MAHARASHTRA 		 9359691943

shubhamrahane7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N399||Disorder of urinary system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine  1 microgram/kg Clonidine as adjuvant to 0.25% of 1ml/kg of bupivacaine approximate duration of procedure is 2 to 3 minutes. 
Intervention  Dexmedetomidine  1 microgram/kg Dexmedetomidine as adjuvant to 0.25% of 1 ml /kg of bupivacaine approximate duration of procedure is 2 to 3 minutes. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Pediatric patients from 2 yrs to 6 years.
2. ASA grade I-II
3. Pediatric patients undergoing infraumbilical surgeries like hernia repair, circumcisions, orchidopexy, etc.
 
 
ExclusionCriteria 
Details  1.Children less than 2 yrs or more than 6 yrs.
2.ASA grade III –IV.
3.Known allergy to any of the study drugs.
4.Pre-operative hepatic or renal dysfunction.
5.Serious cardiac or respiratory disease.
6.History of developmental delay or mental retardation.
7.Known or suspected coagulopathy.
8.Signs of infection at the site of the proposed caudal block. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare caudal epidural bupivacaine with clonidine & bupivacaine with dexmedetomidine regarding the duration of analgesia in pediatric patients posted for infraumbilical surgeries under general anesthesia  12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the synergistic effect & safety of adding dexmedetomidine to bupivacaine compared with clonidine to bupivacaine in caudal block in infraumbilical surgeries.
To compare the haemodynamic changes during intraoperative and postoperative period.
To compare the quality and duration of postoperative analgesia.
To compare the total amount of rescue analgesics used during the 12 hour post operative period.
To study the side effects and complications during the post operative period.
 		 12 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/01/2024 
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)   Not Applicable 
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 analgesia is an accepted and popular method of providing intra- and post-operative analgesia for infra abdominal surgeries in children. Bupivacaine is the most commonly used local anaesthetic for this purpose. The limitation of bupivacaine is the short duration of action, about four to six hours, when administered as a ‘single shot technique’. Several adjuncts such as opioids, ketamine, midazolam, clonidine and neostigmine have been used with bupivacaine to prolong its action(de Beer and Thomas, 2003), and thus extend the duration of post-operative analgesia provided by the ‘single shot’ caudal technique. Clonidine, an alpha 2 agonist has extensively been used in neuraxial blocks(S et al., 1994) and peripheral nerve blocks to prolong the action of bupivacaine. Dexmedetomidine is a useful non-opioid drug used to manage pain and sedation.

PRIMARY OBJECTIVES:

To compare caudal epidural bupivacaine with clonidine and bupivacaine with dexmedetomidine regarding the duration of analgesia in pediatric pts. posted for infraumbilical surgeries under GA.

SECONDARY OBJECTIVES:

To assess the synergistic effect and safety of adding dexmedetomidine to bupivacaine compared with clonidine to bupivacaine in caudal block in infraumbilical surgeries.

To compare the haemodynamic changes during intraoperative and postoperative period.

To compare the quality and duration of postoperative analgesia.

To compare the total amount of rescue analgesics used during the 12 hour post operative period.

To study the side effects and complications during the post operative period.

METHODOLOGY: Patients for the study will be conducted on 50 patients fulfilling the inclusion criteria. Patients will be randomly allocated into 2 study groups who will be administered with the following combination of drugs.
Group B will receive bupivacaine.25%(1ml/kg) and Group C will receive bupivacaine .25%(1ml/k) with clonidine 1 µ/kg in normal saline 1 ml. 

 
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