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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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