| CTRI Number |
CTRI/2025/11/097204 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying the effect of medicine ketamine versus dexamethasone in making children pain free after tonsil surgery |
|
Scientific Title of Study
|
Comparision of topical ketamine versus dexamethasone for post tonsillectomy pain relief in paediatric patients- a prospective study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chennelli sai spoorthi |
| Designation |
Resident |
| Affiliation |
RIMS medical college |
| Address |
Department of Anaesthesiology, old hospital building,2nd floor, OT Complex RIMS medical college,
Adilabad
Adilabad
TELANGANA
504001
India |
| Phone |
9182389580 |
| Fax |
|
| Email |
rithikasharmaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himani |
| Designation |
Associate professor |
| Affiliation |
RIMS medical college |
| Address |
Department of Anaesthesiology, old hospital building,2nd floor, OT Complex RIMS medical college,
Adilabad
Adilabad
TELANGANA
504001
India |
| Phone |
8500974476 |
| Fax |
|
| Email |
himani51187@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Supraja ponduru |
| Designation |
Assistant professor |
| Affiliation |
RIMS medical college |
| Address |
Department of Anaesthesiology, old hospital building,2nd floor, OT Complex RIMS medical college,
Adilabad
TELANGANA
504001
India |
| Phone |
8500974476 |
| Fax |
|
| Email |
smileysu.supraja@gmail.com |
|
|
Source of Monetary or Material Support
|
| RIMS MEDICAL COLLEGE, Adilabad, Telangana,504001 |
|
|
Primary Sponsor
|
| Name |
RIMS medical college |
| Address |
RIMS medical college,
Adilabad,
Telangana, India, 504001 |
| 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 |
| Supraja ponduru |
RIMS medical college |
Department of Anaesthesiology, old hospital building,2nd floor, OT Complex RIMS medical college,
Adilabad
Adilabad
TELANGANA |
8500974476
smileysu.supraja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
human volunteers undergoing tonsil surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexamethasone |
dose 0.2mg per KG, single dose, topical application at the end of surgery |
| Intervention |
ketamine |
dose 2mg per KG, single dose, topical application at the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
elective tonsillectomy surgery |
|
| ExclusionCriteria |
| Details |
peritonsillar abscess
bleeding diathesis
syndromic children
congenital abnormalities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess pain scores in the immediate postoperative period |
0 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative hemodynamics, postoperative nausea and vomiting, sedation, bleeding, time to rescue analgesia |
0 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="6"
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
|
Tonsillectomy is very commonly performed surgery in children and is associated with significant postoperative pain. Various methods were opted over period for postoperative pain relief including intravenous ketamine and dexamethasone. In our study we aim to compare topical application of ketamine versus dexamethasone for postoperative analgesia in patients undergoing tonsillectomy. ketamine at a dose of 2mg per kg as a single dose will be applied topically in the fossa aloowing a contact period of 5 min, similarly dexamethasone at a dose of 0.2 mg per kg will be applied topically in the other group. parameters like postoperative pain scores, postoperative nausea and vomiting, sedation score, bleeding, need for rescue analgesia will be documented and studied. |