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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Selcuk University
- Enrollment
- 200
- Primary Endpoint
- Quality of view, ease of procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who undergone diagnostic nasal endoscopy between 2015- 2017
Exclusion Criteria
- •Had experienced nasal endoscopy before
- •Allergic to either xylometazoline or lidocaine
- •Cardiovascular disease
- •Severe septal deviation
Arms & Interventions
Hypertonic sea water
The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.
Intervention: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization (Other)
Lidocaine
The patient was applied intranasal Vemcaine as TLA (10% lidocaine; AstraZeneca, Södertälje, Sweden) before the nasoendoscopy procedure.
Intervention: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization (Other)
Xylometazoline
The patient was applied intranasal Otrivine (0.1% xylometazoline hydrochloride, GlaxoSmithKline, Brentford, UK ) before the nasoendoscopy procedure.
Intervention: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization (Other)
0.9% Sodium chloride
The patient was applied intranasal placebo (0.9% sodium chloride) before the nasoendoscopy procedure.
Intervention: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization (Other)
Outcomes
Primary Outcomes
Quality of view, ease of procedure
Time Frame: 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 Outcomes
- Post-op pain(2 years)
- Post-op discomfort(2 years)
Investigators
Merih Onal
Associate Professor
Selcuk University