| CTRI Number |
CTRI/2025/07/089993 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Postoperative Pain Control: A Combination Approach with Paracetamol and Dexamethasone |
|
Scientific Title of Study
|
"Efficacy of Combined Paracetamol and Dexamethasone Analgesia in Postoperative Pain Management Following ENT Surgery: A Randomized Controlled 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 Ramya |
| Designation |
Junior Resident |
| Affiliation |
Sri Ramachandra institute of medical sciences and research institutes |
| Address |
6th block ,ladies hostel,Ramachandra nagar,
Ramachandra university
Chennai
TAMIL NADU
600116
India |
| Phone |
9940941962 |
| Fax |
|
| Email |
rvr9098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arulmurugan |
| Designation |
Professor |
| Affiliation |
Government |
| Address |
Department of Anaesthesiology Sri Ramachandra Institute of Higher Education and Research center
Ramachandra univerity
Chennai
TAMIL NADU
600116
India |
| Phone |
9380537411 |
| Fax |
|
| Email |
rampond@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrArulmurugan |
| Designation |
Professor |
| Affiliation |
|
| Address |
Deparment of Anaesthesiology
Sri Ramachandra institute of Higher Education and Research center
Ramachandra nagar
Ramachandra univerity
Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9380537411 |
| Fax |
|
| Email |
rampond@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA UNIVERSITY |
| Address |
Department of Anesthesiology RAMACHANDRA NAGAR
SRI RAMACHANDRA UNIVERSITY
PORUR |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Arulmururugan |
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH HOSPITAL |
Ramachandra nagar
Chennai
TAMIL NADU |
9940941962
rvr9098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H708||Other mastoiditis and related conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
"Efficacy of Combined Paracetamol and Dexamethasone vs. Paracetamol Alone for Postoperative Pain Management in ENT Surgery: A Randomized, Controlled Trial." |
Combining paracetamol and dexamethasone for postoperative pain management in ENT surgery offers enhanced pain relief compared to paracetamol alone, particularly in the immediate postoperative period. Dexamethasone, an anti-inflammatory and antiemetic, when used with paracetamol, can reduce pain scores and the need for opioid analgesics. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
Asa 1 and 2
All elective ENT surgeries done under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient refusal to give consent
Allergy to paracetamol and dexamethasone
Emergency cases
Patients on steroid therapy
Patients having condition for which paracetamol cand dexamethasone contraindicated
ASA 4 and ASA 5 |
|
|
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 |
| Postoperative pain score |
Postoperative pain score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
POSTOPERATIVE NAUSEA VOMITING
NO OF POSTOPERATIVE ANALGESIC REQUIREMENT |
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
11/07/2025 |
| 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="0"
Months="1"
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
|
Paracetomol and dexamethasone are both used in postoperative pain management,but they both work through different mechanism.Paracetomol is an analgesic that reduces pain and dexamethasone is a corticosteroid that reduces inflammation by the way it helps in encountering postoperative pain and nausea vomiting.Combining both the drugs will be effective than using either drug alone ,potentially leading to better pain control and reducing opioid requirement and antiemetic use |