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

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinki University Central Hospital
• Treatments: Anesthetics; Anesthetics, Local; Carticaine

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