Intranasal Lidocaine Spray Versus Nasogastric Tube Administration in the Emergency Room

NCT ID: NCT07103915

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-08-15

Brief Summary

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.

Detailed 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.

Conditions

Nasogasrtic Tube Insertion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

%10 lidocaine spray

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

Group Type: EXPERIMENTAL

Lidocaine 10% Spray

Intervention Type: DRUG

This study evaluates whether intranasal 10% lidocaine spray reduces pain and improves first-pass success during nasogastric tube (NGT) insertion compared to placebo.

Placebo

Drug: Placebo Spray (Ethanol-matched solution without lidocaine)

Two sprays in each nostril, same protocol

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Drug: Placebo Spray (Ethanol-matched solution without lidocaine)

Interventions

Lidocaine 10% Spray

This study evaluates whether intranasal 10% lidocaine spray reduces pain and improves first-pass success during nasogastric tube (NGT) insertion compared to placebo.

Intervention Type: DRUG

Placebo

Drug: Placebo Spray (Ethanol-matched solution without lidocaine)

Intervention Type: OTHER

Other Intervention Names

Xylocaine nasal spray; Placebo nasal spray

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Alp Şener

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kadir Yenal

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent City Hospital Emergency Medicine Department

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

No:E1-23-3927

Identifier Type: -

Identifier Source: org_study_id