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

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ClinicalTrials.gov Identifier: NCT02105090
Recruitment Status : Recruiting
First Posted : April 7, 2014
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Mihkel Meinberg, 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.

Condition or disease Intervention/treatment Phase
Dyspepsia Hematemesis Abdominal Pain Heartburn Drug: Anesthetics, Local Drug: Sodium Chloride 0.9% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS) [ Time Frame: within 30 minutes after the procedure ]
  2. Cumulative consumption of alfentanil during the procedure (mg) [ Time Frame: 30 minutes after the procedure ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105090


Contacts
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Contact: Mihkel Meinberg, MD +358504286766 mihkel.meinberg@hus.fi
Contact: Reino Pöyhiä, MD, PhD +35894711 reino.poyhia@hus.fi

Locations
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Finland
Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Mihkel Meinberg, MD    +358504286766    mihkel.meinberg@hus.fi   
Contact: Reino Pöyhiä, MD, PhD    +35894711    reino.poyhia@hus.fi   
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         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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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:

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Responsible Party: Mihkel Meinberg, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02105090     History of Changes
Other Study ID Numbers: 2012-005528-13
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Keywords provided by Mihkel Meinberg, Helsinki University Central Hospital:
Upper gastrointestinal tract
Endoscopy
Lozenge
Articaine
Dyspepsia
Hematemesis
Abdominal pain
Heartburn
Additional relevant MeSH terms:
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Dyspepsia
Hematemesis
Abdominal Pain
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pathologic Processes
Vomiting
Anesthetics
Carticaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents