An interventional study of Lidocaine 10% Spray and Placebo in Nasogasrtic Tube Insertion, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
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.
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.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 120 is above the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.
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Exclusion Criteria:
Drug: Lidocaine 10% Spray Two sprays in each nostril administered 1 minute prior to NGT insertion
Drug: Lidocaine 10% Spray
Drug: Placebo Spray (Ethanol-matched solution without lidocaine) Two sprays in each nostril, same protocol
Other: Placebo
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
Drug: Placebo Spray (Ethanol-matched solution without lidocaine)
Also known as: Placebo nasal spray
First-Pass Success Rate
Rate of initial procedure success
Time frame: 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.
Time frame: During nasogastric tube insertion
Nasogastric tube insertion time
Evaluation of nasogastric tube insertion time with/without Lidocaine spray
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes after completion of insertion
Overall Procedure Success
Successful NGT placement, regardless of number of attempts.
Time frame: Within 5 minutes of placement
Plan to share: Yes — Individual participant data will be shared upon reasonable request by journal editors.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Ankara City Hospital Bilkent