| CTRI Number |
CTRI/2023/07/055681 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of effect of intranasal ketamine on postoperative pain in children |
|
Scientific Title of Study
|
Study of effect of intranasal ketamine on postoperative analgesia in children - A one year single blinded hospital based randomized placebo controlled clinical trial |
| 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 APOORVA S |
| Designation |
Junior Resident |
| Affiliation |
KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
KLE JAWAHARLAL NEHRU MEDICAL COLLEGE
Belgaum
KARNATAKA
590010
India |
| Phone |
9480945052 |
| Fax |
|
| Email |
appuanju1410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VANDANA GOGATE |
| Designation |
PROFESSOR |
| Affiliation |
KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
JAWAHARLAL NEHRU MEDICAL COLLEGE
Belgaum
KARNATAKA
590010
India |
| Phone |
98440830830 |
| Fax |
|
| Email |
vandanagogate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VANDANA GOGATE |
| Designation |
PROFESSOR |
| Affiliation |
KLE UNIVERSITY JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
JAWAHARLAL NEHRU MEDICAL COLLEGE
Belgaum
KARNATAKA
590010
India |
| Phone |
98440830830 |
| Fax |
|
| Email |
vandanagogate@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY,
JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI,
KARNATAKA 590010 |
|
|
Primary Sponsor
|
| Name |
DR APOORVA S |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI,
KARNATAKA 590010 |
| 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 APOORVA S |
KLE’s Dr. Prabhakar Kore Hospital |
Department of Anaesthesiology, Nehru Nagar,
Belgaum
KARNATAKA |
9480945052
appuanju1410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Intervention |
Ketamine |
1mg/kg of Intranasal Ketamine will be instilled with atomizer after the completion of the surgical procedure and once the closure starts. |
| Comparator Agent |
Normal saline |
Equal amount as that of intervention through intranasal route will be instilled with atomizer after the completion of the surgical procedure and once the closure starts. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.CHILDREN IN THE AGE GROUP 5 TO 18 YEARS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA
2. CHILDREN IN ASA GRADE I TO II |
|
| ExclusionCriteria |
| Details |
CHILDREN WITH
1. ALLERGIC TO STUDY DRUG
2. ASA GRADE III OR > III
3. ABERRANT NASAL ANATOMY THAT PRECLUDES INTRANASAL MEDICATIONS.
4. PATIENTS UNDERGOING ANY NASAL SURGERY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessement for postoperative pain after intranasal administration of ketamine |
At 15, 30,45,60 min,
2,6, 12, 24 hours post operatively using modified Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) and Visual Analog Scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the total amount of analgesic |
Anagesia required in first 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/08/2023 |
| 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 Applicable |
| 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
|
KETAMINE, A NMDA antagonist has been extensively used for induction of general anaethesia . It’s use in subanaestheic doses for analagesia is being explored. Hence, this study is being undertaken to study the effect of intranasal ketamine in post operative pain relief. |