Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03380715
Other study ID # julius
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2016
Est. completion date August 1, 2018

Study information

Verified date December 2017
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Malaysia Hospital Tengku Ampuan rahimah Klang Selangor
Malaysia University of Malaya Medical center Kuala Lumpur Wilayah Persekutuan

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Age Age in years Pre-procedure
Secondary Gender Male/female Pre-procedure
Secondary BMI Body Mass Index Pre-procedure
Secondary VAS (Visual analogue score) pain score VAS (Visual analogue score) pain score Pre-procedure and 30 minutes after introduction of nasal spray/nebulizer
Secondary nasal flow rate nasal flow rate in ml/s Pre-procedure and 5,10,15 and 30 minutes after introduction of nasal spray/nebulizer
See also
  Status Clinical Trial Phase
Completed NCT02360072 - Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
Completed NCT02340130 - Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma Phase 2
Completed NCT01118312 - Study of Asthma and Nasal Steroids Phase 4
Completed NCT00762567 - Phenylephrine Pediatric Pharmacokinetic Study Phase 1
Completed NCT00541255 - A Long-Term Examination of Asthma From Childhood Through Adolescence
Completed NCT00279916 - Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays Phase 3
Completed NCT00963573 - Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428) Phase 4
Completed NCT00524836 - Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis Phase 3
Completed NCT00521131 - Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites Phase 4
Completed NCT04132570 - A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution Phase 4
Completed NCT02784262 - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis Phase 2
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Terminated NCT02630472 - Topical Irrigation Therapy for CRS Phase 1/Phase 2
Completed NCT02279706 - Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test N/A
Completed NCT01971086 - Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary N/A
Completed NCT01771120 - Control and Burden of Asthma and Rhinitis N/A
Completed NCT01469234 - A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712) Phase 4
Withdrawn NCT01177852 - Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis Phase 3
Completed NCT02879929 - Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction N/A
Completed NCT00724698 - Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria