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CTRI Number  CTRI/2017/03/008245 [Registered on: 29/03/2017] Trial Registered Retrospectively
Last Modified On: 28/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between caudal Dexmedetomidine and Morphine 
Scientific Title of Study   Comparison of caudal Dexmedetomidine versus Morphine as an adjunct to Bupivacaine in children undergoing lower abdominal surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lt Col Amit Rai 
Designation  Associate Professor 
Affiliation  ARMED FORCES MEDICAL COLLEGE 
Address  Department of Anaesthesiology and Critical Care Armed Forces Medical College Solapur Road Pune

Pune
MAHARASHTRA
411040
India 
Phone  08411052137  
Fax    
Email  drraiamit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Venkata Krishna G 
Designation  Post graduate trainee/junior resident 
Affiliation  Armed Forces Medical College 
Address  Department of Anaesthesiology and Critical Care Armed Forces Medical College Solapur Road, Pune

Pune
MAHARASHTRA
411040
India 
Phone  08551901713  
Fax    
Email  dr.gvk63217@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Venkata Krishna G 
Designation  Post graduate trainee/junior resident 
Affiliation  Armed Forces Medical College 
Address  Department of Anaesthesiology and Critical Care Armed Forces Medical College Solapur Road Pune

Pune
MAHARASHTRA
411040
India 
Phone  08551901713  
Fax    
Email  dr.gvk63217@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care Armed Forces Medical College Solpur Road, Pune- 411040 Maharashtra 
 
Primary Sponsor  
Name  Armed forces Medical College Pune 
Address  Department Of Anaesthesiology and Critical Care, Armed Forces Medical College,Solapur Road,Pune 
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 
Lt Col Amit Rai  OT COMPLEX, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE  COMMAND HOSPITAL(SOUTHERN COMMAND) WANOWRIE, PUNE-411041
Pune
MAHARASHTRA 		 08411052137

drraiamit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE, AFMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pediatric patients undergoing lower abdominal surgeries under General Anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caudal Dexmedetomidine  Dexmeditomidine 1 micro gram /kg + 1 ml/Kg 0.25 % Bupivacaine through caudal epidural route as single shot. 
Comparator Agent  Caudal Morphine  Morphine 50 micro gram/Kg + 1 ml/Kg 0.25 % Bupivacaine through caudal epidural route as single shot 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II
2. Pediatric patients between 2-10 yeras
undergoing lower abdominal surgeries
3. Written informed parental consent
4. Elective surgery

 
 
ExclusionCriteria 
Details  1. Known allergy to study drugs
2. History of developmental delay or mental retardation
3. Patients with coagulopathies
4. Signs of infection at the site of caudal block
5. Skeletal deformities in the caudal region
6. Patient or parental refusal
6. Neurological disorder or deficit

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the post operative analgesia produced by Dexmeditomidine and Morphine when used as additive to bupivacaine (using FLACC pain scale with 0-10 score range)  In post anesthesia care unit and every 2 Hourly 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the post operative sedation when Dexmedetomidine and Morphine used as adjuncts to Bupivacaine in caudal block(using modified Ramsay Sedation Scale)  In Post Anaesthesia Care Unit and every 4 hrly 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/04/2016 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT APPLICABLE 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 Caudal epidural blocks are the most commonly used technique providing intra and postoperative analgesia in pediatric lower abdominal surgeries. Caudal  anlgesia proved to be simple and effective technique.Inspite of using long acting local anaesthetics, the main disadvantage of caudal analgesia remains the relatively short duration of action.The practice of adding adjunct analgesic drugs to local anesthetics for caudal block is common.  Clinically, the addition of both morphine and dexmedetomidine prolongs the duration of caudal analgesia. Aim of the study is to compare the analgesic effects of  Dexmedetomidine and morphine  as  adjuncts  to Bupivacaine in caudal block.


 
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