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Completed

NCT Number: NCT07103915

Intranasal Lidocaine Spray Versus Nasogastric Tube Administration in the Emergency Room

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.

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Key information

Conditions

Nasogasrtic Tube Insertion Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital Emergency Medicine Department

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Xylocaine nasal spray

Placebo

Other

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

Other names: Placebo nasal spray

Primary outcomes

  1. First-Pass Success Rate

    Time frame: During initial NGT insertion attempt

    Rate of initial procedure success

  2. Insertion pain score

    Time frame: 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.

Secondary outcomes

  1. Nasogastric tube insertion time

    Time frame: During procedure (in seconds)

    Evaluation of nasogastric tube insertion time with/without Lidocaine spray

  2. Patient satisfaction

    Time frame: Immediately after procedure

    Patient preference for the subsequent attempts:Patient satisfaction will be evaluated immediately after the procedure by asking the participant which method they would prefer if a nasogastric tube were needed again. Preference will be recorded as an indicator of satisfaction. The unit of measure is "patient-reported preference (yes/no)." Higher willingness to repeat the same method is interpreted as higher satisfaction.

  3. Pain Score at 5 Minutes

    Time frame: 5 minutes after completion of insertion

    Measured on the same Numeric Rating Scale(NRS):Pain intensity will be assessed using the Numeric Rating Scale (NRS), a validated tool ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. The score will be recorded 5 minutes after the completion of the insertion procedure. Higher scores correspond to greater pain intensity.

  4. Overall Procedure Success

    Time frame: Within 5 minutes of placement

    Successful NGT placement, regardless of number of attempts.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Patient Satisfaction and the Effectiveness of Intranasal Lidocaine Spray Versus Nasogastric Tube Administration in the Emergency Room

Acronym: Lidocaine

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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