| CTRI Number |
CTRI/2019/12/022479 [Registered on: 20/12/2019] Trial Registered Prospectively |
| Last Modified On: |
18/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparitive study of caudal clonidine versus dexmedetomidine for post operative analgesia in paediatric patients |
|
Scientific Title of Study
|
COMPARITIVE STUDY OF CAUDAL CLONIDINE WITH ROPIVACAINE VERSUS DEXMEDETOMIDINE WITH ROPIVACAINE FOR POST OPERATIVE ANALGESIA IN PEADIATRIC PATIENTS |
| Trial Acronym |
COMPARITIVE STUDY OF CAUDAL CLONIDINE VERSUS DEXMEDETOMIDINE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R PAUL RAFSON JANI |
| Designation |
Junior resident in anaesthesia |
| Affiliation |
Mgm ECHRS |
| Address |
mgm medical college
resident doctors quarters room no 20, aurangabad
Department of Anaesthesia
5th floor
Mgm medical college and hospital Aurangabad
Aurangabad
MAHARASHTRA
431006
India |
| Phone |
9500144229 |
| Fax |
|
| Email |
rafson55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod bhale |
| Designation |
Professor in anaesthesia |
| Affiliation |
MGM ECHRS |
| Address |
mgm medical college
resident doctors quarters room no 20, aurangabad
Department of Anaesthesia
5th floor MGM medical college
Aurangabad
Aurangabad
MAHARASHTRA
431006
India |
| Phone |
8888819021 |
| Fax |
|
| Email |
pramod.bhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R PAUL RAFSON JANI |
| Designation |
Junior resident in anaesthesia |
| Affiliation |
MGM ECHRS |
| Address |
mgm medical college
resident doctors quarters room no 2o, aurangabad
Department of Anaesthesia
5th floor hospital
MGM medical college
Aurangabad
Aurangabad
MAHARASHTRA
431006
India |
| Phone |
9500144229 |
| Fax |
|
| Email |
rafson55@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
mgm medical college |
| Address |
N6 cidco aurangabad - 431003
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rafson |
mgm medical college aurangabad |
N6 CIDCO
AURANGABAD 431001
Aurangabad
MAHARASHTRA |
9500144229
rafson55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECHRS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
elective below umblical surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
clonidine 1mcg/kg |
caudal block |
| Comparator Agent |
dexmedetomidine 1mcg/kg |
caudal block |
| Intervention |
ropivacaine 0.25 % 1 ml/kg |
caudal block |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.asa grade 1 and 2
2.children between 2 to 6 age group
3.elective below umblical surgeries |
|
| ExclusionCriteria |
| Details |
1.children with local infection at the caudal region
2.coagulopathy
3.pre existing neurological or obvious spinal diseases
4.history of developmental delay and congenital anomaly
5.known allergy to study drug
6.refusal of parents |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of post operative analgesia |
0,1,2,4,6,8,10,12,16,20,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of complications |
1,2,3,4,8,16,24 hours |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 4 |
|
Date of First Enrollment (India)
|
22/12/2019 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
paediatric patients caudal epidural block is one of the safe and effective technique that can provide analgesia for intra operatively and post operatively ,the use of caudal epidural catheters are not popular are because of the risk of infection. prolongation of the duration of anaesthesia is acheived by addition of various additives such as opiods,alpha 2 agonists, ropivacaine is extensively used because of its less cardiovascular and neurological toxicity. clonidine is an alpha 2 agonist which prolongs the duration and dexmedetomidine has 8 fold higher affinity for alpha 2 adrenergic receptors and much alpha 1 effect. so we conducted the study to compare the post operative duration of analgesis between these drugs |