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

Selcuk University

Status and phase: Completed; Phase 4

Conditions: Nasopharyngeal Diseases

Treatments: Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

Study type: Interventional

Funder types: Other

Identifiers

NCT04214938

15.01.2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups, including a placebo group

Hypertonic sea water

Active Comparator group

Description:

The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.

Treatment:

Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

Lidocaine

Active Comparator group

Description:

The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure.

Treatment:

Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

Xylometazoline

Active Comparator group

Description:

The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure.

Treatment:

Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization

0.9% Sodium chloride

Placebo Comparator group

Description:

The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure.

Treatment:

Other: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization