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

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

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.

Study Overview

• Status: Completed
• Conditions: Nasopharyngeal Diseases
• Intervention / Treatment: Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hypertonic sea water; The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.	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.; Other Names: intranasal hypertonic sea water (Ancient Secrets, USA); intranasal lidocaine (Vemcaine AstraZeneca, Södertälje, Sweden); intranasal xylometazoline (Otrivine, GlaxoSmithKline, Brentford, UK); intranasal isotonic saline (Deva, Istanbul, TR)
ACTIVE_COMPARATOR: Lidocaine; The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure.	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.; Other Names: intranasal hypertonic sea water (Ancient Secrets, USA); intranasal lidocaine (Vemcaine AstraZeneca, Södertälje, Sweden); intranasal xylometazoline (Otrivine, GlaxoSmithKline, Brentford, UK); intranasal isotonic saline (Deva, Istanbul, TR)
ACTIVE_COMPARATOR: Xylometazoline; The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure.	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.; Other Names: intranasal hypertonic sea water (Ancient Secrets, USA); intranasal lidocaine (Vemcaine AstraZeneca, Södertälje, Sweden); intranasal xylometazoline (Otrivine, GlaxoSmithKline, Brentford, UK); intranasal isotonic saline (Deva, Istanbul, TR)
PLACEBO_COMPARATOR: 0.9% Sodium chloride; The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure.	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.; Other Names: intranasal hypertonic sea water (Ancient Secrets, USA); intranasal lidocaine (Vemcaine AstraZeneca, Södertälje, Sweden); intranasal xylometazoline (Otrivine, GlaxoSmithKline, Brentford, UK); intranasal isotonic saline (Deva, Istanbul, TR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (ACTUAL): January 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 30, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: lidocaine; discomfort; isotonic saline; hypertonic saline solutions; oxymetazoline
• Additional Relevant MeSH Terms: Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Respiratory System Agents; Vasoconstrictor Agents; Nasal Decongestants; Lidocaine; Xylometazoline
• Other Study ID Numbers: 15.01.2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No