Intranasal Lidocaine Spray Versus Nasogastric Tube Administration in the Emergency Room

Ankara City Hospital

Status: Completed

Conditions: Nasogasrtic Tube Insertion

Treatments: Drug: Lidocaine 10% Spray; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07103915

No:E1-23-3927

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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:
• Ileus
• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

%10 lidocaine spray

Experimental group

Description:

Drug: Lidocaine 10% Spray Two sprays in each nostril administered 1 minute prior to NGT insertion

Treatment:

Drug: Lidocaine 10% Spray

Placebo

Placebo Comparator group

Description:

Drug: Placebo Spray (Ethanol-matched solution without lidocaine) Two sprays in each nostril, same protocol

Treatment:

Other: Placebo