UnknownPhase 4

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

Finland120 participantsStarted 2014-10

Plain-language 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.

Who can participate

Age range20 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale).

Timeframe: 30 minutes after the procedure

Trial details

NCT IDNCT02105090

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Contact for this trial

Mihkel Meinberg, MD

+358504286766 mihkel.meinberg@hus.fi

View on ClinicalTrials.gov More Dyspepsia trials