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

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ClinicalTrials.gov Identifier: NCT03380715
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
University of Malaya

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.


Condition or disease Intervention/treatment Phase
Anaesthesia Rhinitis Device: Nasal nebulisation into the right nostril Device: Nasal Spray into the right nostril Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Comparison Between Co-phenylcaine Nasal Spray and Nasal Nebulization Prior to Rigid Nasoendoscopic Examination
Actual Study Start Date : May 13, 2016
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : May 1, 2019

Arm Intervention/treatment
Active Comparator: right nostril in patients with rhinitis
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
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 Spray into the right nostril
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

No Intervention: Left nostril in patients with rhinitis
No nasal decongestion administration into the left nostril
Active Comparator: Right nostril in patients with rhinitis
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
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 Spray into the right nostril
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




Primary Outcome Measures :
  1. Change in Nasal resistance [ Time Frame: Pre-procedure and 5,10,15 and 30 minutes after introduction of nasal spray/nebulizer ]
    Change in Nasal resistance in Pa/cm3/s


Secondary Outcome Measures :
  1. Age [ Time Frame: Pre-procedure ]
    Age in years

  2. Gender [ Time Frame: Pre-procedure ]
    Male/female

  3. BMI [ Time Frame: Pre-procedure ]
    Body Mass Index

  4. VAS (Visual analogue score) pain score [ Time Frame: Pre-procedure and 30 minutes after introduction of nasal spray/nebulizer ]
    VAS (Visual analogue score) pain score

  5. nasal flow rate [ Time Frame: Pre-procedure and 5,10,15 and 30 minutes after introduction of nasal spray/nebulizer ]
    nasal flow rate in ml/s



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380715


Contacts
Contact: Goh Liang Chye, MBBS +60123238755 juliusglc@hotmail.com

Locations
Malaysia
Hospital Tengku Ampuan rahimah Recruiting
Klang, Selangor, Malaysia, 41200
Contact: Goh Liang Chye, MBBS         
Principal Investigator: Goh Liang Chye, MBBS         
University of Malaya Medical center Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
Contact: Goh Liang Chye, MBBS    +60123238755    juliusglc@hotmail.com   
Sponsors and Collaborators
University of Malaya

Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT03380715     History of Changes
Other Study ID Numbers: julius
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Malaya:
Sinusitis
Endoscopy
Rhinitis

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Lidocaine
Phenylephrine
Oxymetazoline
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents