Nasogasrtic Tube InsertionLidocaineNCT07103915
Intranasal Lidocaine Spray Versus Nasogastric Tube Administration in the Emergency Room
A study testing Lidocaine 10% Spray in people with Nasogasrtic Tube Insertion, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasogasrtic Tube Insertion
- What is being tested?
- Lidocaine 10% Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Intoxication
- Provided written informed consent
- Did not meet any of the exclusion criteria
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Emergency Medicine Department
Ankara
About this study
Official title: Patient Satisfaction and the Effectiveness of 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:
Read more
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.
Read the 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
- Being tested
- Lidocaine 10% Spray, Placebo
- Keywords
- intranasal lidocaine, numeric rating scale, Pain, Lidocaine spray, nasogastric tube
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 10% SprayDrug
Also called Xylocaine nasal spray
This study evaluates whether intranasal 10% lidocaine spray reduces pain and improves first-pass success during nasogastric tube (NGT) insertion compared to placebo.
PlaceboOther
Also called Placebo nasal spray
Drug: Placebo Spray (Ethanol-matched solution without lidocaine)
| Study group | Role | What they receive |
|---|---|---|
| %10 lidocaine spray | Experimental | Drug: Lidocaine 10% Spray Two sprays in each nostril administered 1 minute prior to NGT insertion Receives: Drug: Lidocaine 10% Spray |
| Placebo | Placebo comparator | Drug: Placebo Spray (Ethanol-matched solution without lidocaine)
Two sprays in each nostril, same protocol Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-Pass Success Rate
Rate of initial procedure success
Measured: 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.
Measured: During nasogastric tube insertion
Secondary outcomes (4)
Nasogastric tube insertion time
Evaluation of nasogastric tube insertion time with/without Lidocaine spray
Measured: During procedure (in seconds)
Patient satisfaction
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.
Measured: Immediately after procedure
Pain Score at 5 Minutes
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.
Measured: 5 minutes after completion of insertion
Overall Procedure Success
Successful NGT placement, regardless of number of attempts.
Measured: Within 5 minutes of placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Nov 2023
- Primary completion30 Jun 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasogasrtic Tube InsertionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, placebo-controlled, double-blind study, single centered
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Şener, Ankara City Hospital Bilkent
- Investigators
- Kadir Yenal, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103915
- Sponsor's protocol ID
- No:E1-23-3927
- Acronym
- Lidocaine
- Status last verified
- Aug 2025
- First submitted
- 25 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon reasonable request by journal editors.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and the Effectiveness of Intranasal Lidocaine Spray Versus Nasogastric Tube Administration in the Emergency Room
- ClinicalTrials.gov ID
- NCT07103915
- Acronym / sponsor ID
- Lidocaine / No:E1-23-3927
- Conditions
- Nasogasrtic Tube Insertion
- Keywords
- intranasal lidocaine, numeric rating scale, Pain, Lidocaine spray, nasogastric tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, placebo-controlled, double-blind study, single centered
| Arm | Type | Receives |
|---|---|---|
| %10 lidocaine spray | Experimental | Drug: Lidocaine 10% SprayDrug: Lidocaine 10% Spray Two sprays in each nostril administered 1 minute prior to NGT insertion |
| Placebo | Placebo comparator | Other: PlaceboDrug: Placebo Spray (Ethanol-matched solution without lidocaine) Two sprays in each nostril, same protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- Hemodynamic instability (hypotension, tachycardia, tachypnea, or hypoxia)
- Cognitive impairment or inability to cooperate
- Hearing or visual impairment
- Inability to sit upright
- History of epistaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 10% SprayAlso: Xylocaine nasal sprayThis study evaluates whether intranasal 10% lidocaine spray reduces pain and improves first-pass success during nasogastric tube (NGT) insertion compared to placebo. | Drug | %10 lidocaine spray |
| PlaceboAlso: Placebo nasal sprayDrug: Placebo Spray (Ethanol-matched solution without lidocaine) | Other | Placebo |
Primary outcome
First-Pass Success Rate
Time frame: During initial NGT insertion attempt
Rate of initial procedure success
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.
4 secondary outcomes
Nasogastric tube insertion time
Time frame: During procedure (in seconds)
Patient satisfaction
Time frame: Immediately after procedure
Pain Score at 5 Minutes
Time frame: 5 minutes after completion of insertion
Overall Procedure Success
Time frame: Within 5 minutes of placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon reasonable request by journal editors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kadir Yenal principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 10% Spray in people with Nasogasrtic Tube Insertion, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-Pass Success Rate (time frame: During initial NGT insertion attempt). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.