| CTRI Number |
CTRI/2025/10/096187 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| 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 on the Effect of Fentanyl Nasal Pack in Reducing Pain After nasal Surgeries Among Adults in Wayanad |
|
Scientific Title of Study
|
EFFECT OF FENTANYL NASAL PACK IN
REDUCING POST-OPERATIVE PAIN AMONG ADULT POPULATION UNDERGOING SEPTAL AND TURBINATE SURGERIES IN TERTIARY CARE CENTRE IN WAYANAD DURING 2025-2027-A RANDOMISED CONTROL 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 Pallavi T Joy |
| Designation |
PG Resident |
| Affiliation |
Dr.Moopens Medical College Hospital |
| Address |
Department of Otorhinolaryngology
2nd Floor
Dr.Moopens Medical College
Naseera Nagar
Meppadi Wayanad
Wayanad KERALA 673577 India |
| Phone |
8891460236 |
| Fax |
|
| Email |
pallavitjoy123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhishek R |
| Designation |
Professor |
| Affiliation |
Dr.Moopens Medical College Hospital |
| Address |
Department of Anaesthesiology
7th Floor
Dr.Moopens Medical College
Naseera Nagar
Meppadi Wayanad
Wayanad KERALA 673577 India |
| Phone |
7795098801 |
| Fax |
|
| Email |
abhishek.r@drmoopensmc.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Pallavi T Joy |
| Designation |
PG Resident |
| Affiliation |
Dr.Moopens Medical College Hospital |
| Address |
Department of Otorhinolaryngology
2nd Floor
Dr.Moopens Medical College
Naseera Nagar
Meppadi Wayanad
Wayanad KERALA 673577 India |
| Phone |
8891460236 |
| Fax |
|
| Email |
pallavitjoy123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Moopens Medical College |
| Address |
Dr.Moopens Medical College
Naseera Nagar
Meppadi Wayanad
Pin-673577 |
| Type of Sponsor |
Private 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 |
| Dr Pallavi T Joy |
Dr.Moopens Medical College Hospital |
Department of Otorhinolaryngology
2nd Floor
Dr.Moopens Medical College
Naseera Nagar
Meppadi Wayanad
673577 Wayanad KERALA |
8891460236
pallavitjoy123@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 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% isotonic saline |
used to soak the nasal packs in the control group, placed in the nasal cavity for 24 hours, identical in procedure to the fentanyl packs but without the active drug. |
| Intervention |
Fentanyl nasal packing |
Fentanyl citrate is diluted for nasal use.25 mcg applied per nasal cavity using gauze/cottonoids soaked in the solution.The pack left for 24 hrs for analgesia and hemostasis.continous monitoring required due to possible systemic absorption and respiratory depression. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18–65 years
2.Undergoing elective nasal surgery(septoplasty/Turbinate
surgeries)requiring nasal packing |
|
| ExclusionCriteria |
| Details |
1. Allergy or hypersensitivity to opioids, Chronic opioid use or
substance abuse
2. Nasal pathology that may alter drug absorption
3. Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study represents a step forward in the use of fentanyl for managing acute nasal pain, particularly postoperative nasal pain. While many hospitals already employ intravenous fentanyl for postoperative pain control, our findings demonstrate that topical intranasal administration is both localized and effective. |
Assessments were conducted at 1,2,4,8 and 24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
07/11/2025 |
| 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
|
Fentanyl Citrate is commonly used in injectable form and diluted with saline for nasal application. A standard dose of 25 micrograms is applied to each nasal cavity. The preparation involves mixing 1 milliliter of 50 micrograms per milliliter fentanyl with 4 milliliters of saline to make a concentration of 10 micrograms per milliliter. Gauze or cotton is soaked in this solution and inserted into the nose for 24 hours to provide pain relief and reduce bleeding. Continuous monitoring is essential due to the risk of systemic absorption and respiratory depression.
The experimental group receives nasal packing with fentanyl while the control group gets saline. Pain is measured at 1, 2, 4, 8, and 24 hours using a numeric scale from 0 to 10. Patient satisfaction is rated on the same scale. The same medical staff records all data to ensure consistency. Additional pain relief includes intravenous paracetamol and tramadol, given if needed and recorded.
Risks include respiratory depression, sedation, opioid toxicity, allergic reactions, and nasal irritation. A qualified safety officer monitors for adverse effects. Emergency protocols are in place. Adverse effects are reported to the ethics board within 24 hours.
Stopping rules include two or more cases of respiratory depression or one confirmed overdose. Staff are trained in opioid safety and emergency procedures. Data is collected systematically and kept confidential through secure storage and deidentification.
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