| CTRI Number |
CTRI/2023/02/049650 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain difference between fentanyl and saline soaked nasal pack after Functional Endoscopic Sinus Surgery |
|
Scientific Title of Study
|
Effect of Fentanyl soaked nasal pack in pain management after Functional Endoscopic Sinus Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANANTHULA SAHAJA |
| Designation |
POST GRADUATE RESIDENT-MS ENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
LNRDH,MAMC CAMPUS,BAHADUR SHAH ZAFAR MARG,NEW DELHI-110002
New Delhi
DELHI
110002
India |
| Phone |
8309750572 |
| Fax |
|
| Email |
ananthulasahaja10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar Rathore |
| Designation |
Director Professor and Head |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Third floor,ENT and Head and Neck Surgery Department,B L Taneja Block, Maulana azad Medical College,Lok Nayak Hospital,Central Delhi
Central
DELHI
110002
India |
| Phone |
9868100337 |
| Fax |
|
| Email |
praveen.rathore61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar Rathore |
| Designation |
Director Professor and Head |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Third floor,ENT and Head and Neck Surgery Department,B L Taneja Block, Maulana azad Medical College,Lok Nayak Hospital,Central Delhi
North West
DELHI
110002
India |
| Phone |
8309750572 |
| Fax |
|
| Email |
praveen.rathore61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital,Bahadur shah zafar marg,New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College,2,Bahadur Shah Zafar Marg,New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Praveen Kumar Rathore |
MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED LOK NAYAK HOSPITAL, BAHADUR SHAH ZAFAR MARG, NEW DELHI |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ananthula Sahaja |
LOKNAYAK HOSPITAL |
ENT OPD And Department of ENT
Central
DELHI |
8309750572
ananthulasahaja10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITALS ( LOK NAYAK HOSPITAL, GOVIND BALLABH PANT INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH HOSPITAL, GURU NANAK EYE CENTRE), NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl soaked merocele nasal pack |
After functional endoscopic sinus surgery nasal packing will be done using 50 MICROGRAM(1ml) fentanyl(test) soaked merocele -post op pain measured in terms of visual analogue scale at 0,4,10,24,48hrs,during pack removal and its effect on pain compared with normal saline(control) soaked pack at similar time intervals |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronic rhinosinusitis with pansinusitis,maxillary sinusitis |
|
| ExclusionCriteria |
| Details |
Revision surgery
Bony erosions
Complications of sinusitis
Intracranial complications
Comorbidities
Substance abuse
History of drug allergies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses pain relief in terms of visual analogue scale |
0hr,4hr,10hr,24hr,48hr,pack removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess patient satisfaction by numeric rating scale.
To assess sedative effect in terms of Ramsay sedation scale |
0hr,4hr,10hr,24hr,48hr,pack removal time |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
13/02/2023 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIMS AND OBJECTIVES
AIM: To study the effect of fentanyl soaked pack on pain relief after Functional Endoscopic Sinus Surgery.
PRIMARY OBJECTIVE: To assess the pain relief after Functional Endoscopic Sinus Surgery with Fentanyl soaked nasal pack as compared to normal saline soaked nasal pack.
SECONDARY OBJECTIVE: To assess patient satisfaction and sedative effect of fentanyl soaked nasal pack after Functional Endoscopic Sinus Surgery.
CONCLUSION: Fentanyl
soaked nasal packs(topical) can be safely used after FESS surgery with
significant decrease in pain without significant side effects.
|