| CTRI Number |
CTRI/2024/11/076335 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparision of intravenous ibuprofen versus intravenous paracetamol in Functional Endoscopic Sinus Surgery |
|
Scientific Title of Study
|
A Prospective randomized controlled study on comparison of intravenous Ibuprofen and Paracetamol for post operative pain relief in functional endoscopic sinus surgeries (FESS) |
| 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 LGeetha Ramalakshmi |
| Designation |
post Graduate |
| Affiliation |
SRM Medical college hospital and research centre |
| Address |
Room no 1.B block anaesthesia department SRM Medical college
hospital and Research Centre SRM nagar, Potheri Chengalpattu
district Kanchipuram Tamil Nadu - 603203 India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9944559112 |
| Fax |
|
| Email |
vasanthasaigeetha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrR Balaji |
| Designation |
Professor |
| Affiliation |
SRM Medical college hospital and research centre |
| Address |
Room no 1.B block anaesthesia department SRM Medical college
hospital and Research Centre SRM nagar, Potheri Chengalpattu
district Kanchipuram Tamil Nadu - 603203 India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9677053310 |
| Fax |
|
| Email |
aarbee79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrR Balaji |
| Designation |
Professor |
| Affiliation |
SRM Medical college hospital and research centre |
| Address |
Room no 1.B block anaesthesia department SRM Medical college
hospital and Research Centre SRM nagar, Potheri Chengalpattu
district Kanchipuram Tamil Nadu - 603203 India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9677053310 |
| Fax |
|
| Email |
aarbee79@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical collage Hospital and Research centre,SRM nagar,potheri,chengalpattu district,tamil nadu 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical collage Hospital and Research centre |
| Address |
Room no 5, B block,SRM Medical collage hospital and research
centre SRMNAGAR,potheri,chengalpattu district kanchipuram,
Tamil Nadu-603203 |
| 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 |
| DrKKarthick |
SRM Medical collage Hospital and Research centre |
SRM Medical collage Hospital and Research centre
kattangulathur 603203
Kancheepuram
TAMIL NADU |
9444586662
karthikk1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College A Hospital And Research Centre |
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 |
Group I |
Inj.Ibuprofen 400 mg IV is administered 15 min before the end of procedure for FESS and pain intensity is measured using VAS score postoperatively |
| Comparator Agent |
Group P |
Inj.Paracetamol 1 gm IV is administered 15 min before the end of procedure for FESS and pain intensity is measured using VAS score Post operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 Patients
patient weight between 50 to 80 kg |
|
| ExclusionCriteria |
| Details |
Hepatic disease and renal disorders
History of GERD and peptic ulcer
History of drug allergy
patient with coagulation abnormality |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Post operative analgesia |
assessment of VAS score at 0hour,4hours,8hours,12hours, 16hours,20hours and 24 hours, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS score during first 24 hrs of postoperative period
Total amount of NSAID used
Total amount of rescue analgesic used
|
0 to 24 hrs after the end of procedure |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/11/2024 |
| 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="0"
Months="6"
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
|
This study will be performed in patients scheduled to undergo FESS surgery under general anesthesia. A written informed consent will be obtained from the participants. The participants will be allocated into two groups by computer-generated random numbers group I is Ibuprofen and group P is paracetamol. Anaesthesia premedication and induction will be standardized among two groups. The surgeon will be asked to infiltrate with plain adrenaline not xylocaine with adrenaline for local site infiltration. ibuprofen 400mg and paracetamol 1gm will be administered in the respective groups 15 min before the end of the procedure and patient will be shifted to post anaesthesia care unit and pain intensity will be monitored using VAS score for 24 hrs. if the VAS score >4 ibuprofen and paracetamol will be repeated in the respective groups and inj.tramadol 100mg iv will be administered if needed as a second rescure analgesic.
|