Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
Phase 4
- Conditions
- HematemesisHeartburnDyspepsiaAbdominal Pain
- Interventions
- Drug: Anesthetics, Local
- Registration Number
- NCT02105090
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sodium chloride 0.9% Sodium Chloride 0.9% Sodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy Articaine hydrochloride 2% Anesthetics, Local Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy Articaine hydrochloride 1% Anesthetics, Local Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
🇫🇮Helsinki, Uusimaa, Finland