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

Helsinki University Central Hospital (HUCH)

Status and phase: Unknown; Phase 4

Conditions: Heartburn; Dyspepsia; Hematemesis; Abdominal Pain

Treatments: Drug: Anesthetics, Local; Drug: Sodium Chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT02105090

2012-005528-13

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

120 participants in 3 patient groups, including a placebo group

Sodium chloride 0.9%

Placebo Comparator group

Description:

Sodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy

Treatment:

Drug: Sodium Chloride 0.9%

Articaine hydrochloride 1%

Experimental group

Description:

Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy

Treatment:

Drug: Anesthetics, Local

Articaine hydrochloride 2%

Experimental group

Description:

Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy

Treatment:

Drug: Anesthetics, Local