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

Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study

Sponsors

Lead Sponsor: Helsinki University Central Hospital

Source 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.

Overall Status Recruiting
Start Date 2014-10-01
Completion Date 2020-09-01
Primary Completion Date 2019-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
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 Outcome
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
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Anesthetics, Local

Other Name: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08

Intervention Type: Drug

Intervention Name: Sodium Chloride 0.9%

Arm Group Label: Sodium chloride 0.9%

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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Mihkel Meinberg, MD

Phone: +358504286766

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital Mihkel Meinberg, MD +358504286766 [email protected] Mihkel Meinberg, MD Principal Investigator Kalle Jokelainen, MD, PhD Sub-Investigator Harri Mustonen, MD, PhD Sub-Investigator Hannamari Hakojärvi, Pharm.D Sub-Investigator Anne Juppo, Pharm.D, PhD Sub-Investigator Pertti Pere, MD, PhD Sub-Investigator
Location Countries

Finland

Verification Date

2019-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Helsinki University Central Hospital

Investigator Full Name: Mihkel Meinberg

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Sodium chloride 0.9%

Type: Placebo Comparator

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

Label: Articaine hydrochloride 1%

Type: Experimental

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

Label: Articaine hydrochloride 2%

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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