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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Quality of view, ease of procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The caregiver administering the nasal spray, the subject, and the otolaryngologist carrying out nasendoscopy were all uninformed as to the type of spray employed.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who undergone diagnostic nasal endoscopy between 2015- 2017
排除标准
- •Had experienced nasal endoscopy before
- •Allergic to either xylometazoline or lidocaine
- •Cardiovascular disease
- •Severe septal deviation
研究组 & 干预措施
Hypertonic sea water
The patient was applied intranasal hypertonic sea water (3.5% sodium chloride) before the nasoendoscopy procedure.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization (Other)
结局指标
主要结局
Quality of view, ease of procedure
时间窗: 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)
次要结局
- Post-op pain(2 years)
- Post-op discomfort(2 years)
研究者
Merih Onal
Associate Professor
Selcuk University