Efficacy of Fentanyl Soaked Nasal Packs on Postoperative Pain in Nasal Surgeries.

NCT06531759 | Not Yet Recruiting Phase 2

• 1 other identifier: Pain after nasal surgeries
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries

  Assessment of pain intensity will be done using The 11-point Numeric pain rating scale, subjects will be asked to give a pain score ranging from 0 to 10 interpreted as 0 is no pain and 10 is the worst pain they ever felt at intervals of 3, 6, 12 and 24 hours postoperatively.

  24 hours postoperatively

Study Arms (1)

Patients undergoing nasal surgeries requiring bilateral nasal packs.

OTHER

After performing the required nasal surgery, hydroxylated polyvinyl acetate packs (known as merocele packs) will be applied bilaterally in patients. The merocele on the left side will be injected with 5 ml volume of normal saline, while The merocele pack in the right side will be injected with 5 ml volume of the diluted fentanyl solution (1ml of fentanyl 50mcg diluted in 10 ml of normal saline).

Drug: Fentanyl

Interventions

Fentanyl DRUG

Fentanyl soaked nasal packs.

Patients undergoing nasal surgeries requiring bilateral nasal packs.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing nasal surgeries requiring bilateral nasal packs.
• Patients 18 years or older.

You may not qualify if:

• Patients in whom fentany is contraindicated such as respiratory comorbidites (COPD and Asthma), hypersensitivity to fentanyl, liver diseases or had previous biliary tract surgeries
• Systemic medical problems interfering with surgery.
• Patients with traumatic conditions e.g fracture face or fracture nasal bone.
• patients who refuse to take part in the study.
• Patients with different nasal pathology in both sides e.g if partial turbinectomy is indicated in one side of the nose or patients with unilateral nasal polyp.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Aya M. Abd ElMonem, Bachelor

CONTACT

01098242701; aia90713@gmail.com

Hamza ElShafiy

CONTACT

01002906798; Hamza_shafy@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aya Mahmoud Abd ElMonem

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07