Nasogasrtic Tube Insertion
Conditions
Keywords
intranasal lidocaine, numeric rating scale, Pain, Lidocaine spray, nasogastric tube
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.
Interventions
This study evaluates whether intranasal 10% lidocaine spray reduces pain and improves first-pass success during nasogastric tube (NGT) insertion compared to placebo.
OTHERPlacebo
Drug: Placebo Spray (Ethanol-matched solution without lidocaine)
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blind
Intervention model description
prospective, randomized, placebo-controlled, double-blind study, single centered
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-Pass Success Rate | During initial NGT insertion attempt | Rate of initial procedure success |
| Insertion pain score | 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
| Measure | Time frame | Description |
|---|---|---|
| Nasogastric tube insertion time | During procedure (in seconds) | Evaluation of nasogastric tube insertion time with/without Lidocaine spray |
| Patient satisfaction | 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. |
| Pain Score at 5 Minutes | 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. |
| Overall Procedure Success | Within 5 minutes of placement | Successful NGT placement, regardless of number of attempts. |
Countries
Turkey (Türkiye)
Outcome results
None listed