| 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
|
|
|
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
|
|
|
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. |