| CTRI Number |
CTRI/2021/03/032151 [Registered on: 19/03/2021] Trial Registered Prospectively |
| Last Modified On: |
24/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of dexmedetomidine versus dexamethasone with levobupivacaine in caudal block for post operative analgesia |
|
Scientific Title of Study
|
A Comparative study of dexmedetomidine versus dexamethasone as an adjuvant to 0.2% levobupivacaine in caudal block for post operative analgesia in paediatric patients undergoing infraumbilical surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Laxmi |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal nehru medical college, ajmer |
| Address |
Department of anesthesiology jln medical college and associated group of hospitals, ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
7073690374 |
| Fax |
|
| Email |
laxmibishnoi129@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena mathur |
| Designation |
Senior professor , department of anesthesiology |
| Affiliation |
Jawaharlal nehru medical college ,ajmer |
| Address |
Department of anesthesiology jln medical college and associated group of hospitals, ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9351270664 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena mathur |
| Designation |
Senior professor , department of anesthesiology |
| Affiliation |
Jawaharlal nehru medical college ,ajmer |
| Address |
Department of anesthesiology jln medical college and associated group of hospitals, ajmer Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9351270664 |
| Fax |
|
| Email |
veenamathur41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru medical college ajmer |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru medical college ajmer |
| Address |
Department of anesthesiology JLN medical college and associated group of hospitals Ajmer Rajasthan |
| Type of Sponsor |
Government 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 |
| Dr LAXMI |
Jawaharlal nehru medical college and associated group of hospitals |
Department of anesthesiology, jln medical college and associated group of hospitals, ajmer Rajasthan
Ajmer
RAJASTHAN |
7073690374
laxmibishnoi129@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee, JLN medical college, Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine and dexamethasone to levobupivacaine in caudal block |
Addition of dexmedetomidine .75mcg/kg and dexamethasone 0.1 mg/kg to levobupivacaine 0.2% in caudal block for postoperative analgesia in paediatric patients |
| Comparator Agent |
Dexmedetomidine versus dexamethasone as an adjuvant to 0.2% levobupivacaine in caudal block for post operative analgesia in paediatric patients undergoing infraumbilical surgeries |
Group A- 0.2% levobupivacaine .75ml/kg+ inj dexmedetomidine .75mcg/kg given as caudal epidural analgesia as single shot injection
Group B- 0.2% levobupivacaine .75ml/kg + inj dexamethasone .1mg/kg given as caudal epidural analgesia as a single shot injection |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.patients between the age group of 1year and 8year of both sexes undergoing various infraumbilical surgeries
2. Patients belonging to ASA 1 and 2 grades
3.parental consent |
|
| ExclusionCriteria |
| Details |
1.patients with known allergy to the study drugs
2. Suspected coagulopathy
3. Infection at site of caudal block
4.History of developmental delay and neurological diseases
5. Skeletal deformities in the caudal region
6.parental refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of study will be assesment of Duration of analgesia (from the time of caudal injection to the time at which FLACC pain Pain score 4 or more) |
Duration of study will be around 1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome of study will be assesment of 1.postoperative sedation
2. Hemodynamic changes
3.total number of doses of rescue analgesia in 24 hours |
Duration of study will be around 1year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2021 |
| Date of Study Completion (India) |
31/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The aim of study will be to compare the efficacy and safety of addition of dexmedetomidine versus dexamethasone to caudal 0.2% levobupivacaine on postoperative analgesia in paediatric patients undergoing infraumbilical surgeries
Primary objective will be to assess duration of analgesia (from the time of caudal block to the time at which FLACC Pain score 4 or more)
Secondary objective will be to assess 1.postoperative sedation 2. Hemodynamic changes 3.Total number of doses of rescue analgesia in 24 hours |