Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy

Study Overview
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Brief Summary
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The purpose of this study is to examine in prospective, double-blinded randomised manner the ability of novel articaine-containing lozenge to enhance the procedure related compliance (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.

Official Title
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Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study

Conditions
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Dyspepsia, Hematemesis, Abdominal Pain, Heartburn

Intervention / Treatment
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* Drug: Anesthetics, Local
* Drug: Sodium Chloride 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective procedure weight over 40 kg American Society of Anesthesiology class I-III first upper GI endoscopy procedure finnish or/and swedish speaking Exclusion Criteria: amide and/or esther local anaesthetic allergy paraben allergy Child-Pugh grade B/C liver failure renal insufficiency (calculated glomerular filtration rate under 60 ml/min/1.73 m2 according to Cockcroft-Gault scale ) dementia those presenting with swallowing problem chronic pain condition chronic use of pain medication pregnancy lactation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sodium chloride 0.9%<br>Sodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy | Drug: Sodium Chloride 0.9%<br> <br> |
| Experimental: Articaine hydrochloride 1%<br>Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy | Drug: Anesthetics, Local<br> <br> * Other names: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08;|
| Experimental: Articaine hydrochloride 2%<br>Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy | Drug: Anesthetics, Local<br> <br> * Other names: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale). |  | 30 minutes after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS) |  | within 30 minutes after the procedure | 
| Cumulative consumption of alfentanil during the procedure (mg) |  | 30 minutes after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper gastrointestinal tract, Endoscopy, Lozenge, Articaine, Dyspepsia, Hematemesis, Abdominal pain, Heartburn