A Comparison Between Co-phenylcaine Nasal Spray and Nasal Nebulization Prior to Rigid Nasoendoscopic Examination

NCT03380715 | Completed

• 1 other identifier: julius
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

Co-phenylcaine is a widely available nasal spray commonly used by otorhinolaryngologists for the purpose of decongestion and local anesthetic prior to a nasoendoscopic or nasopharyngolaryngoscopy. It is often used in the outpatient setting and is also useful for minor procedures. It is unique in its properties because it provides both local anesthetic and decongestive effects on the nasal mucosa hence leading to better visualization of the nasal cavity and better comfort for the patient during the procedure. Pharmacologically, Co-phenylcaine Forte comprises of a combination of Lignocaine 5% (50mg/ml) and phenylephrine 0.5% (5mg/ml) and is commonly marketed in a 50ml bottle attached to a disposable positive displacement atomizer which avoids contamination by preventing contamination of the nozzle tip by secretions from other patients which are commonly seen in older venturi devices.Its decongestive agent (phenylephrine) acts by influencing the sympathetic vasculature tone via alpha adrenoceptors since its properties are sympathomimetic and oppose vasodilation.As for the local anesthethic component (Lignocaine) , it is an amide local anesthetic which blocks fast voltage gated sodium channels in the cell membrane thus leading to a decrease in sensation when performing a nasoendoscopy. Despite of its advantages, there are also disadvantages in the usage of such a device such as the need for regular change of the nozzle head due to the risk of infection and the high cost of using this device in the long run. Several studies has demonstrated promising results for the efficacy of nebulized medication and its distribution of medication into the nasal cavity and paranasal sinuses in both healthy individuals and cadaver models.Its advantages over the classical nasal spray include better distribution of medication throughout the nasal cavity and better hygiene due to the ability to change and sterilize the nasal nozzle tip before re-usage. Very little information is available about the delivery of topical decongestants via nasal nebulization on the pre-endoscopic examination of the nasal cavity. This study aims to compare the efficacy of topical decongestants delivered into the nasal cavity using nasal nebulization against the delivery of topical decongestants using conventional nasal sprays.

Conditions

Anaesthesia; Rhinitis

Keywords

Sinusitis; Endoscopy; Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in Nasal resistance

  Change in Nasal resistance in Pa/cm3/s

  Pre-procedure and 5,10,15 and 30 minutes after introduction of nasal spray/nebulizer

Secondary Outcomes (5)

• Age

  Pre-procedure

• Gender

  Pre-procedure

• BMI

  Pre-procedure

• VAS (Visual analogue score) pain score

  Pre-procedure and 30 minutes after introduction of nasal spray/nebulizer

• nasal flow rate

  Pre-procedure and 5,10,15 and 30 minutes after introduction of nasal spray/nebulizer

Study Arms (3)

right nostril in patients with rhinitis

ACTIVE COMPARATOR

Intervention : Administration of either 4 sprays of nasal decongestions(Co-Phenylcaine(400mcl) (20mg lidocaine + 2mg phenylephrine) once into the right nasal cavity or

Device: Nasal nebulisation into the right nostril; Device: Nasal Spray into the right nostril

Left nostril in patients with rhinitis

NO INTERVENTION

No nasal decongestion administration into the left nostril

Right nostril in patients with rhinitis

ACTIVE COMPARATOR

400mcl of co-phenylcaine (20mg of lidocaine + 2mg of phenylephrine) is added into the nasal nebuliser device (Rinowash Nebula, Air liquid medical systems) and the solution is diluted with 4.5cc of isotonic normal saline. This Mixture is then nebulised into the right nasal cavity for approximately 3 minutes.The seated patient's head is kept flexed and nebulizer device is kept sealed within the nasal cavity while the nebulisation is done and subsequently checking nasal resistance after nasal nebulisation.

Device: Nasal nebulisation into the right nostril; Device: Nasal Spray into the right nostril

Interventions

Nasal nebulisation into the right nostril DEVICE

400mcl of co-phenylcaine (20mg of lidocaine + 2mg of phenylephrine) is added into the nasal nebuliser device (Rinowash Nebula, Air liquid medical systems) and the solution is diluted with 4.5cc of isotonic normal saline. This Mixture is then nebulised into the right nasal cavity for approximately 3 minutes.The seated patient's head is kept flexed and nebulizer device is kept sealed within the nasal cavity while the nebulisation is done and subsequently checking nasal resistance after nasal nebulisation.

Right nostril in patients with rhinitis; right nostril in patients with rhinitis

Nasal Spray into the right nostril DEVICE

Intervention : Administration of 4 sprays of nasal decongestions(Co-Phenylcaine(400mcl) (20mg lidocaine + 2mg phenylephrine) once into the right nasal cavity using a nasal spray and subsequently checking nasal resistance post nasal spray

Right nostril in patients with rhinitis; right nostril in patients with rhinitis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-40 years of age regardless of race of gender.
• Patients requiring the use of a rigid nasoendoscopy for the diagnosis of nasal pathology

You may not qualify if:

• Patients with underlying systemic medical problems. e.g. Bronchial Asthma, Chronic lung disease, Diabetes, Chronic Kidney disorder, Cerebrovascular accidents (CVA),SLE
• Patients who have nasal pathologies such as nasal polyps, inverted papillomas, malignancies, deviated nasal septums, septal perforations, deformed external nose, cleft palates.
• Patients with a history of nasal surgery
• Patients with a history of intranasal topical medications (E.g Intranasal oxymetazoline,)
• Patients who are pregnant and are breastfeeding.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (2)

University of Malaya Medical center

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Hospital Tengku Ampuan rahimah

Klang, Selangor, 41200, Malaysia

Location

MeSH Terms

Conditions

Rhinitis; Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: December 21, 2017
• Study Start: May 13, 2016
• Primary Completion: March 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)