Patient Satisfaction and the Effectiveness of Intranasal Lidocaine Spray Versus Nasogastric Tube Administration in the Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- First-Pass Success Rate
研究概览
简要总结
The goal of this clinical trial is to evaluate whether 10% intranasal lidocaine spray reduces pain and improves the success rate of nasogastric tube (NGT) insertion compared to placebo in adult emergency department patients.
The study's primary outcomes were:
Procedure success rate (first-pass success)
Pain during insertion, measured by the Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "worst possible pain".
The secondary outcomes included:
Duration of the procedure (in seconds)
Overall success rate (eventual successful insertion regardless of attempts)
Pain score at the 5th minute post-procedure (NRS)
Patient preference for the same method in future procedures (yes/no)
Procedure satisfaction, assessed using an NRS-based score from 0 ("not satisfied at all") to 10 ("completely satisfied").
Participants were randomized to receive either lidocaine or placebo spray intranasally before standard NGT insertion. Pain, success rate, and satisfaction were compared between groups.
详细描述
This randomized controlled trial aims to evaluate the effect of intranasal lidocaine 10% spray on patient comfort and pain during nasogastric tube (NGT) insertion in the emergency department. NGT placement is often associated with significant discomfort and anxiety, which can reduce procedural success and patient cooperation.
Eligible adult patients requiring nasogastric tube insertion in the emergency setting will be randomly assigned to receive either intranasal lidocaine spray or a placebo spray prior to the procedure. Both groups will undergo standard NGT placement performed by emergency physicians.
The primary outcome of the study is the level of pain experienced during the procedure, assessed using the Visual Analog Scale (VAS). Secondary outcomes include patient satisfaction, ease of tube placement from the clinician's perspective, vital signs during the procedure, and any adverse effects related to the spray or procedure.
The study seeks to determine whether intranasal lidocaine spray improves procedural comfort and increases overall satisfaction during a commonly performed yet unpleasant emergency intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Presentation to the emergency department during the study period and research assistant's working hours
- •Clinical indication for nasogastric tube (NGT) insertion, including:
- •Gastrointestinal bleeding monitoring
- •Oral feeding difficulties due to neurological or similar disorders
- •Intoxication
- •Provided written informed consent
- •Did not meet any of the exclusion criteria
排除标准
- •Hemodynamic instability (hypotension, tachycardia, tachypnea, or hypoxia)
- •Cognitive impairment or inability to cooperate
- •Hearing or visual impairment
- •Inability to sit upright
- •History of epistaxis
- •Use of anticoagulant medication
- •Coagulopathy (elevated PT/aPTT or thrombocytopenia)
- •Increased risk of aspiration
- •Known lidocaine allergy
- •History of arrhythmia, cardiac disease, or cardiac arrest
- •Pregnancy
- •Nasopharyngeal obstructive pathology
- •Facial or nasal trauma preventing NGT insertion
- •Refusal to participate in the study
研究组 & 干预措施
%10 lidocaine spray
Drug: Lidocaine 10% Spray Two sprays in each nostril administered 1 minute prior to NGT insertion
干预措施: Lidocaine 10% Spray (Drug)
Placebo
Drug: Placebo Spray (Ethanol-matched solution without lidocaine)
Two sprays in each nostril, same protocol
干预措施: Placebo (Other)
结局指标
主要结局
First-Pass Success Rate
时间窗: During initial NGT insertion attempt
Rate of initial procedure success
Insertion pain score
时间窗: During nasogastric tube insertion
Numerical Rating Scale:Level of pain experienced during nasogastric tube insertion, as reported by the patient using the Numerical Rating Scale (NRS). The NRS is a validated 10-point scale ranging from 1 (no pain) to 10 (worst imaginable pain). Higher scores reflect more intense pain perception.
次要结局
- Nasogastric tube insertion time(During procedure (in seconds))
- Patient satisfaction(Immediately after procedure)
- Pain Score at 5 Minutes(5 minutes after completion of insertion)
- Overall Procedure Success(Within 5 minutes of placement)
研究者
Alp Şener
Associate professor
Ankara City Hospital Bilkent