Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures

Nasopharyngeal Diseases Clinical Trial

Official title:

Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures: A Double Blind, Randomized, Controlled Trial Comparing the Efficacy of Intranasal Hypertonic Saline, Xylometazoline, Lidocaine, and Isotonic Saline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214938
• Other study ID #: 15.01.2015
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: December 2019
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 1, 2019
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasopharyngeal Diseases

Intervention

Other:
• Intranasal 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of view, ease of procedure	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)	2 years
Secondary	Post-op pain	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).	2 years
Secondary	Post-op discomfort	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.	2 years