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

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531759
Enrollment
100
Registered
2024-08-01
Start date
2024-09-01
Completion date
2025-11-30
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

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

Detailed description

Postoperative pain is one of the commonest feared surgical side effect which can lead to patient dissatisfaction. It occurs due to a combination of inflammatory reaction and an injury to neural tissue caused by the surgical incision. Anterior nasal packing is not an innocuous procedure. It causes discomfort/pain (especially upon removal), nasal mucosa trauma, epiphora, local infection, discomfort in swallowing, sleep disturbances and, very rarely, toxic shock and vagal reflex. Although systemic opioids are traditionally used in the management of postoperative pain, their use is still limited by their possible side effects. Opioid drugs mimic the actions of the endogenous opioid peptides by interacting with specific receptors, the opioid receptors which are μ, δ and κ. The μ receptor is important in sensory processing, including the modulation of nociceptive stimuli, extrapyramidal functioning and in limbic and neuroendrocine regulation. There are two subtypes of the μ receptor, a high-affinity μ receptor and a low-affinity μ2 receptor. Recently a third μ subtype has been described that binds opioid alkaloids such as morphine, but has essentially no, or exceedingly low, affinity for the naturally occurring endogenous opioid peptides or non-alkaloid opioids such as fentanyl. Based on the hypothesis that mu (μ) opioid receptor expression increases at the site of inflammation. our study aims to assess the analgesic effect produced by local application of fentanyl through fentanyl soaked nasal packs following different nasal surgeries.

Interventions

DRUGFentanyl

Fentanyl soaked nasal packs.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients undergoing nasal surgeries requiring bilateral nasal packs. 2. Patients 18 years or older.

Exclusion criteria

1. Patients in whom fentany is contraindicated such as respiratory comorbidites (COPD and Asthma), hypersensitivity to fentanyl, liver diseases or had previous biliary tract surgeries 2. Systemic medical problems interfering with surgery. 3. Patients with traumatic conditions e.g fracture face or fracture nasal bone. 4. patients who refuse to take part in the study. 5. 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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of fentanyl soaked nasal packs on postoperative pain in nasal surgeries24 hours postoperativelyAssessment 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.

Contacts

Primary ContactAya M. Abd ElMonem, Bachelor
aia90713@gmail.com01098242701
Backup ContactHamza ElShafiy
Hamza_shafy@yahoo.com01002906798

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026