A Comparison Between Co-phenylcaine Nasal Spray and Nasal Nebulization Prior to Rigid Nasoendoscopic Examination
Condition: Anaesthesia; Rhinitis
MeSH terms: Rhinitis
Study type: Interventional

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.
    

Detailed description: 
      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.

      Patients matching the inclusion criteria, when visiting the Otorhinolaryngology clinic of
      Hospital Tengku Ampuan Rahimah Klang and University Malaya Medical centre (UMMC) who require
      nasoendoscopy, will be invited to take part in this prospective study over 6 months. An
      informed consent will be taken detailing the procedure, study conducted and risks involved
      while participating in the study.

      Upon agreeing to participate, the participant's baseline parameters will be recorded.

      The baseline parameters will be as follows:

        1. Baseline BP ,Age, Gender, Race

        2. Baseline BMI/Weight/Height

        3. Pre procedure anterior Rhinomanometry reading for NIF (Nasal inspiratory flow), Flow
           Sum, Flow INC

             1. Anterior rhinomanometer (ATMOS Rhino 31 model, ATMOS Medzintecknik GmbH & Co.KG) is
                used to document serial changes in nasal air flow throughout the procedure.

             2. Procedure is done with the patient seated,secretions from the nose is cleared prior
                to the procedure.

             3. Nose adapter and hose for pressure measurement is placed in the opposite nostril.

             4. Mask is pressed on to the face to measure the flow while ensuring good fitting.

             5. The patient is asked to breathe in and out while keeping the mouth closed. The
                average of 3 readings are documented.

             1. Procedure is repeated in the opposite nostril.

      2. Baseline NOSE (Nasal obstruction symptom evaluation) score prior to procedure. [Figure 1]
      3. VAS (Visual analogue scale) for pain. [Figure2].

        1. Painful sensation was induced in the right nasal cavity by probing the mucosa overlying
           the inferior turbinate 1cm from the anterior end with the ring ended Jobson-Horne Probe.

        2. Pressure is maintained for about 1 second and the subject is asked to rate the pain
           based on the visual analogue scale (VAS).

        3. 0 represents "no pain "and 10 represents the "worst pain imaginable".

        4. Cut off points for pain VAS recommended are: no pain (0-4mm),mild pain (5-44mm),moderate
           pain (45-74mm), 75-100mm(severe pain).14

      The patient is given a randomized labelled card and is grouped according to the procedure.
      Group A - Nasal spray, Group B - Nasal nebulizer.

      Group A - 4 sprays (400mcl) (20mg lidocaine + 2mg phenylephrine)) of co-phenylcaine are given
      into the right nostril while keeping the left nostril as a control.

      Group B - 400mcl of co-phenylcaine (20mg of lidocaine + 2mg of phenylephrine) is added into
      the nasal nebulizer device (Rinowash Nebula, Air liquid medical systems) and the solution is
      diluted with 4.5cc of isotonic normal saline. This Mixture is then nebulized 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 nebulization is done.

      Post procedure, parameters are recorded 5 minutes, 10 minutes, 15 minutes and 30 minutes post
      procedure

        1. Rhinomanometry readings of both nostrils (Right -tested , Left - Control)

        2. Pain VAS score 30 minutes' post procedure.

        3. BP and PR repeated at 5,10,15 and 30 minutes' post procedure

        4. Rigid Endoscopic examination and VAS based on degree of decongestion and ease of
           endoscopic passage

      Ethical considerations The researchers will seek approval from the National Medical Research
      and Ethics committee (MREC) of the Ministry of health(MOH), Malaysia via the National Medical
      Research Registry (NMRR). All responses are confidential; all respondents are allowed to
      refuse participation in the study.

      Since both medical devices delivers the same drug,the side effects which the participant may
      experience include tremors, palpitations, nausea, vomiting, dizziness, numbness and most
      commonly a transient bitter taste in the mouth for a few minutes. Rarely, the participant may
      develop a hypersensitive reaction towards the offending medication.The risks will be managed
      accordingly and symptomatically and the medication will be stopped immediately if the
      participant develops symptoms during the delivery of the medication. The participant maybe
      admitted to the ward for further monitoring if symptoms become severe.

      The effect of the study product on an unborn child is not known. The participants is advised
      to inform the study doctor immediately if she thinks that she is pregnant during the study.
      If she is pregnant, the study therapy will be discontinued immediately and she will be
      removed from the study. The participant is advised to ask the doctor if he/she needs more
      information on the risks and side effects. The trial staff will inform him/her in a timely
      manner about any new findings or changes about the study product which may affect his/her
      health or willingness to continue in this study. Where necessary, the participant may be
      asked to re-consent to participate.

      All of the participant's information obtained in this study will be kept and handled in a
      confidential manner, in accordance with applicable laws and/or regulations. When publishing
      or presenting the study results, the participant's identity will not be revealed without
      his/her expressed consent. Individuals involved in this study, qualified monitors and
      auditors, the sponsor or its affiliates and governmental or regulatory authorities may
      inspect and copy his/her medical records, where appropriate and necessary. Data is kept in
      both hard and digital copies. Hard copies are kept in lockable cabinets with controlled
      access when not under direct supervision of a member of the research team. The study data is
      kept for at least 5 years and henceforth may be destroyed after the duration has expired.

      The study doctor or the sponsor may due to concerns for the participant's safety, stop the
      study at any time. If the study is stopped early for any reason the participant will be
      informed and arrangements made for the participants future care.

      Plan for data analysis and interpretation The raw data will be processed and entered for data
      analysis starting as soon as the patient is recruited till the end of the study.Data will be
      sorted out and processed on a weekly basis. Data entry, utilizing codes was done using SPSS
      software version 23. Computer assisted analysis will be carried out at the end of the study.

      For the proposed study, sample size was determined by using power study. This power study was
      performed using web based sample size calculator
      (http://www.stat.ubc.ca/~rollin/stats/ssize/n2a.html) which is a very useful tool in medical
      and biological research to determine the sample size. Considering 90% power and 5% marginal
      error (type one error for α value=0.05), this study gives a minimum sample size of 55 per
      group (based on the mean and SD obtained from a recent study [13]). Finally, the
      investigators take 60 sample sizes per group.

      Randomization was done by using a web based randomizer
      http://www.graphpad.com/quickcalcs/randomize1@ 18th March 2016@1500H where the total number
      is separated in 2 groups and each group containing 60 samples. The numbers are randomized and
      printed according to the web based randomizer at the aforementioned date and time. Generated
      numbers are then saved for further reference. The numbers are then placed in envelopes and
      given to the patient. The numbers which are received by the patient will determine the group
      by which the patient is selected into.
    

Intervention name(s): Nasal nebulisation into the right nostril; Nasal Spray into the right nostril
Intervention type(s): Device; Device
Intervention description(s): 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.; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sinusitis; Endoscopy; Rhinitis