Intranasal Lidocaine Spray Versus Nasogastric Tube Administration in the Emergency Room

NCT07103915 | Completed

• 1 other identifier: No:E1-23-3927
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasogasrtic Tube Insertion

Keywords

intranasal lidocaine; numeric rating scale; Pain; Lidocaine spray; nasogastric tube

Outcome Measures

Primary Outcomes (2)

• First-Pass Success Rate

  Rate of initial procedure success

  During initial NGT insertion attempt

• Insertion pain score

  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.

  During nasogastric tube insertion

Secondary Outcomes (4)

• 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

Study Arms (2)

%10 lidocaine spray

EXPERIMENTAL

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

Drug: Lidocaine 10% Spray

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lidocaine 10% Spray DRUG

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

Also known as: Xylocaine nasal spray

%10 lidocaine spray

Placebo OTHER

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

Also known as: Placebo nasal spray

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Emergency Medicine Department

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kadir Yenal

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: prospective, randomized, placebo-controlled, double-blind study, single centered

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 5, 2025
• Study Start: November 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 15, 2024
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data and supporting information will be available throughout the publication process, from August 15, 2024 to August 15, 2026.
• Access Criteria: Access to individual participant data and supporting information will be granted to qualified researchers who submit a reasonable request, including a detailed research proposal. Approved researchers will be able to access anonymized datasets and relevant documentation via a secure data-sharing platform following approval by the study's data access committee.

Locations

TU (1)