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临床试验/NCT03380715
NCT03380715已完成不适用

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

University of Malaya4 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2016年5月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
4
主要终点
Change in Nasal resistance

研究概览

简要总结

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.

详细描述

Objectives General objectives

• To compare the efficacy of co-phenylcaine (Lignocaine + phenylephrine) in the decongestion and anesthesia of the nasal cavity prior to endoscopic examination using nasal nebulization as the delivery device in comparison to conventional nasal spray.

Specific Objectives

  • To objectively assess the degree of nasal patency and nasal inspiratory flow by performing anterior rhinomanometry at pre-procedure and post-procedure at 5, 10, 15, and 30 minutes' interval.
  • To objectively assess the blood pressure (BP) and pulse rate (PR) changes throughout the post procedural intervals.
  • To subjectively assess the pain scores using the Visual analogue scale (VAS) at pre-procedure and post procedure at 5, 10, 15 and 30 minutes' intervals.
  • To subjectively assess the after-taste commonly felt by the patient after the procedure.
  • To subjectively assess the patient's NOSE (Nasal Obstruction symptom evaluation) score prior to the commencement of the medication.

Methodology This will be a multicenter, non blinded, prospective, randomized controlled trial on the comparison of delivery of nasal decongestive agent (Co-phenylcaine) into the nasal cavity using nasal sprays and nasal nebulization techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: Nasal nebulisation into the right nostril (Device)

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

干预措施: Nasal Spray into the right nostril (Device)

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.

干预措施: Nasal nebulisation into the right nostril (Device)

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.

干预措施: Nasal Spray into the right nostril (Device)

结局指标

主要结局

Change in Nasal resistance

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

Change in Nasal resistance in Pa/cm3/s

次要结局

  • BMI(Pre-procedure)
  • VAS (Visual analogue score) pain score(Pre-procedure and 30 minutes after introduction of nasal spray/nebulizer)
  • Age(Pre-procedure)
  • Gender(Pre-procedure)
  • nasal flow rate(Pre-procedure and 5,10,15 and 30 minutes after introduction of nasal spray/nebulizer)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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