Abdominal Pain, Dyspepsia, Heartburn, Hematemesis
Conditions
Keywords
Upper gastrointestinal tract, Endoscopy, Lozenge, Articaine, Dyspepsia, Hematemesis, Abdominal pain, Heartburn
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.
Interventions
DRUGAnesthetics, Local
DRUGSodium Chloride 0.9%
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Finland
Contacts
Primary ContactMihkel Meinberg, MD
Backup ContactReino Pöyhiä, MD, PhD
Outcome results
None listed