Clinical trial NCT02105090: Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
Official title: Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyspepsia
Hematemesis
Abdominal Pain
Heartburn
Keywords: Upper gastrointestinal tract
Endoscopy
Lozenge
Articaine
Dyspepsia
Hematemesis
Abdominal pain
Heartburn
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale).
timeFrame: 30 minutes after the procedure
Secondary outcomes:
measure: Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS)
timeFrame: within 30 minutes after the procedure
measure: Cumulative consumption of alfentanil during the procedure (mg)
timeFrame: 30 minutes after the procedure
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
name: Mihkel Meinberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
name: Reino Pöyhiä, MD, PhD
role: STUDY_CHAIR
References:
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