Nasopharyngeal Diseases
Conditions
Keywords
hypertonic saline solutions, lidocaine, oxymetazoline, isotonic saline, discomfort
Brief summary
Transnasal Flexible Pharyngolaryngoscopy (NPL) is one of the most common and fundamental evaluation procedures in otolaryngologist's practice, performed in both outpatient and ward settings.In the studies the desired properties for an effective topical agent to be used in patients undergoing NPL. To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain. However, to date, no studies have been performed in which intranasal hypertonic saline was used prior to nasal endoscopy.
Detailed description
NPL is a technique that has been used for more than 100 years and increases brightness, magnification and the ability to take still and video images (3). NPL is a simple, safe, cost-effective, and generally well-tolerated procedure. However, a portion of patients may refuse to allow the procedure to be repeated as they find it uncomfortable, intolerable, or painful.To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain and increase the field of view and to reduce the duration of examination and unpleasant sensations for the patient on NPL procedures.This randomised control trial was undertaken to compare the application of nasal hypertonic sea water (3.5%) with nasal lidocaine 10%, topical nasal decongestant xylometazoline 0.1% (OtrivineTM) and nasal isotonic serum physiologic as placebo group in relation to how they effectively improve the adequacy of the examination and if they reduce pain and discomfort associated with endoscopic nasal examination.
Interventions
OTHERIntranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization
Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.
Sponsors
Selcuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The caregiver administering the nasal spray, the subject, and the otolaryngologist carrying out nasendoscopy were all uninformed as to the type of spray employed.
Intervention model description
A Double Blind, Randomized, Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who undergone diagnostic nasal endoscopy between 2015- 2017
Exclusion criteria
* Had experienced nasal endoscopy before * Pregnant * Allergic to either xylometazoline or lidocaine * Asthma * Cardiovascular disease * Rhinitis * Severe septal deviation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of view, ease of procedure | 2 years | The primary outcome was to evaluate clinicians' field of the view according to Visual Analog Scale (VAS) questionnaire survey. Shortly after endoscopy, the endoscopist was asked to indicate the degree of quality of view, ease of procedure on a VAS (1: impossible to pass the endoscope, 100: excellent field of view) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-op pain | 2 years | The secondary outcome was to evaluate the patients' pain after the naso-endoscopy procedure according to Visual Analog Scale (VAS) questionnaire survey. Shortly after endoscopy, subjects were asked to indicate their degree of pain on a VAS (1: no pain, 100: unbearable pain). |
| Post-op discomfort | 2 years | The secondary outcome was to evaluate the patients' discomfort after the nasoendoscopy procedure according to Visual Analog Scale (VAS) questionnaire survey. Shortly after spraying each bottle, subjects were asked to indicate their degree of discomfort on a visual analogue scale (VAS) (1: no discomfort, 100: utmost discomfort). For each spray, one independent scores were obtained from each subject. |
Outcome results
None listed