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CTRI Number  CTRI/2024/04/065745 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 13/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study of Fentanyl and Clonidine to assess analgesia in pediatric patients undergoing lower abdomen surgeries. 
Scientific Title of Study   A comparative study of Fentanyl and Clonidine as additives to plain Bupivacaine in caudal anaesthesia in children for postoperative analgesia in Infraumbilical and Genitourinary 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  Dr Vaidehi Chavan 
Designation  Junior resident 
Affiliation  BJGMC and SGH, Pune 
Address  Department of Anaesthesiology, Ward no. 11, first floor, Sassoon General Hospital, Station Road, Pune-411001

Pune
MAHARASHTRA
411001
India 
Phone  8983741147  
Fax    
Email  vvc3008@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surekha Shinde 
Designation  Professor 
Affiliation  BJGMC and SGH, Pune 
Address  Department of Anaesthesiology, Ward no. 11, first floor, Sassoon General Hospital, Station Road, Pune-411001

Pune
MAHARASHTRA
411001
India 
Phone  8983741147  
Fax    
Email  bjsumedh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sujit KShirsagar  
Designation  Assistant Professor 
Affiliation  BJGMC and SGH, Pune 
Address  Department of Anaesthesiology, Ward no. 11, first floor, Sassoon General Hospital, Station Road, Pune-411001


MAHARASHTRA
411001
India 
Phone  8983741147  
Fax    
Email  bjsujit@gmail.com  
 
Source of Monetary or Material Support  
Sassoon General Hospital, Pune 
 
Primary Sponsor  
Name  Dr Vaidehi Chavan 
Address  Sassoon General Hospital,Pune 
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 Vaidehi Chavan  Sassoon General Hospital, Pune  Paediatric OT, Ward no. 17, Second floor, Sassoon General Hospital, Main building, Station Road, Pune-411001
Pune
MAHARASHTRA 
8983741147

vvc3008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, B.J. Govt Medical College and Sassoon general hospital, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N288||Other specified disorders of kidney and ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Drug  Inj clonidine after intubation. once only. 
Intervention  Drug  Inj fentanyl after intubation. once only. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. ASA physical status 1 and 2,
2. Elective infra-umbilical and genitourinary surgeries
 
 
ExclusionCriteria 
Details  1. Parent unwillingness
2. Infection at block site
3. Bleeding diathesis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia in the postoperative period.  0 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the duration of post operative analgesia provided by each group and associated side effects.  0 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   24/04/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 anesthesia is a common regional technique in pediatric patients ,in children caudal anesthesia is typically combined with general anesthesia for intraoperative supplementation and postoperative analgesia. Children experience pain in the same way as adults, though they may be unable to describe the pain ,postoperative analgesia in children is a challenging hurdle before the anesthesiologist. Good and prolonged postoperative analgesia not only relieves pain in children but also relieves anxiety in parents1. Caudal analgesia is an accepted and popular method of providing intra operative and postoperative analgesia for genitourinary and inguinal surgeries in children, as it is safe, reliable and easy to administer1.

Bupivacaine is the most commonly used local anesthetic for caudal block but its limitation is short duration of action, about 4-6 hours when administered as a single shot technique. Prolongation of caudal block can be achieved by addition of various additives like epinephrine, ketamine, opioids, clonidine, dexmedetomidine and neostigmine. The addition of adjuncts not only increases the effectiveness of a local anesthetic by prolonging and intensifying the sensory blockade but also causes reduction in dose of local anaesthetic agents use.

Ketamine has potential for neurotoxic effects, if inadvertently injected intrathecally and neostigmine is accompanied by 30% incidence of vomiting. Opioids and local anesthetics administered together have synergistic analgesic effects, but carries the risk of respiratory depression. Because of its rapid onset of action and high lipid solubility, fentanyl is considered to be a suitable opioid for caudal administration. The role of Clonidine as an analgesic administered by caudal route is now well established in children. Co-administration of caudal Clonidine with Bupivacaine has been found to prolong analgesia without significant respiratory depression after epidural administration.

This study is to assess the efficacy and safety of Fentanyl and Clonidine in low doses as an adjuvant to Bupivacaine for postoperative analgesia in pediatric genitourinary and infraumbilical surgeries. 
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