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

May 3, 2019 updated by: Mihkel Meinberg, Helsinki University Central Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Recruiting
        • Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mihkel Meinberg, MD
        • Sub-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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Drug: Sodium Chloride 0.9%
Experimental: Articaine hydrochloride 1%
Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Drug: Anesthetics, Local
Other Names:
  • Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08
Experimental: Articaine hydrochloride 2%
Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Drug: Anesthetics, Local
Other Names:
  • Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale).
Time Frame: 30 minutes after the procedure
30 minutes after the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS)
Time Frame: within 30 minutes after the procedure
within 30 minutes after the procedure
Cumulative consumption of alfentanil during the procedure (mg)
Time Frame: 30 minutes after the procedure
30 minutes after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Mihkel Meinberg, MD, Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
  • Study Chair: Reino Pöyhiä, MD, PhD, Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

March 29, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-005528-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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