| CTRI Number |
CTRI/2023/07/055105 [Registered on: 12/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ketamine for pain relief via different routes in children aged 2-6years. |
|
Scientific Title of Study
|
A comparative study of intravenous ketamine plus caudal bupivacaine to caudal bupivacaine plus ketamine for postoperative analgesia in children undergoing inguinal hernia 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 Manoj kumar panwar |
| Designation |
Professor |
| Affiliation |
Indira Gandhi medical college and hospital |
| Address |
Operation theater- 3, Department of Anaesthesiology, IGMC Shimla,HP
Operation theater no. 3, department of anaesthesia Indira Gandhi Medical College and Hospital Ridge Sanjauli Road Lakkar Bazar,Shimla,HP
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018199854 |
| Fax |
|
| Email |
drmkpanwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj kumar panwar |
| Designation |
Professor |
| Affiliation |
Indira Gandhi medical college and hospital |
| Address |
Opetation theater-3, Department of Anaesthesiology, IGMC Shimla
Operation theater- 3, Department of Anaesthesiology Indira Gandhi Medical College and Hospital Ridge Sanjauli Road Lakkar Bazar
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018199854 |
| Fax |
|
| Email |
drmkpanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj kumar panwar |
| Designation |
Professor |
| Affiliation |
Indira Gandhi medical college and hospital |
| Address |
Operation theater no.3, Department of Anaesthesiology, IGMC Shimla
Operation theater no. 3
Indira Gandhi Medical College and Hospital Ridge Sanjauli Road Lakkar Bazar
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018199854 |
| Fax |
|
| Email |
drmkpanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Indira Gandhi medical college and hospital,Shimla Himachal pradesh |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi medical college and hospital |
| Address |
Lakkar bajar sanjauli road shimla Himachal Pradesh |
| 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 Divya garg |
Indira Gandhi medical college andhospital shimla |
Operation theater no. 3, Department of Anaesthesiology
Shimla
HIMACHAL PRADESH |
08219309970
gargdivyagarg8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Expedited review committee of the Institutional ethics committee IGMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparision of caudal vs intravenous effect of ketamine in children |
35 patients of inguinal hernia surgeries will receive caudal block with 0.25% bupivacaine @0.5ml/kg plus preservative free caudal ketamine 0.5ml/kg and 5ml NS intravenous route |
| Intervention |
Comparision of caudal vs intravenous effect of ketamine in children |
35 patients undergoing inguinal hernia surgeries who will receive caudal block with 0.25% bupivacaine 0.5ml/kg and subanaesthetic dose of intravenous ketamine @ 0.3ml/kg totalled to 5ml |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
The study will be carried out in 70 patients in age group of 2years- 6years. ASA I and ASA II after approval by institutional protocol review committee. |
|
| ExclusionCriteria |
| Details |
1.Refusal for consent by parents/ guardian.
2.Children with cardiovascular diseases.
3. Any history of bleeding or clotting disorder.
4. Local infection at the site of needle insertion.
5. History of allergy to local anaesthetics of ketamine.
6. Children with coagulopathy, pilonidal sinus or local site infections. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of prospective pain free period in paediatric patients following administration of subanaesthetic doses of intravenous ketamibe plus caudal bupivacaine to caudal bupivacaine plus ketamine |
24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the duration of pain free period & amount of analgesic consumption in first 24hrs postoperatively |
24hrs |
| To evaluate requirement of rescue analgesia postoperatively |
24hrs |
| Secondary outcome in form of postoperative agitation, sedation etc. |
24hrs |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
19/07/2023 |
| 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 block is commonly performed for postoperative pain management in children undergoing abdominal and lower limb surgeries. Although it has its own contraindications and benefits. Ketamine in subanaesthetic doses possesses centrally mediated analgesic properties with minimal effects on consciousness and cognition of the patient. However whether IV Subanaesthetic ketamine or caudal ketamine provides a level of postoperative analgesia that is similar to caudal bupivacaine in children is unknown.
|