Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
Information source: Helsinki University Central Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyspepsia; Hematemesis; Abdominal Pain; Heartburn
Intervention: Anesthetics, Local (Drug); Sodium Chloride 0.9% (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Helsinki University Central Hospital Official(s) and/or principal investigator(s): Mihkel Meinberg, MD, Principal Investigator, Affiliation: Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital Reino Pöyhiä, MD, PhD, Study Chair, Affiliation: Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Overall contact: Mihkel Meinberg, MD, Phone: +358504286766, Email: mihkel.meinberg@hus.fi
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.
Clinical Details
Official title: Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale).
Secondary outcome: Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS)Cumulative consumption of alfentanil during the procedure (mg)
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Mihkel Meinberg, MD, Phone: +358504286766, Email: mihkel.meinberg@hus.fi
Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital, Helsinki, Uusimaa 00029, Finland; Recruiting Mihkel Meinberg, MD, Phone: +358504286766, Email: mihkel.meinberg@hus.fi Reino Pöyhiä, MD, PhD, Phone: +35894711, Email: reino.poyhia@hus.fi 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
Additional Information
Related publications: Campo R, Brullet E, Montserrat A, Calvet X, Moix J, Rué M, Roqué M, Donoso L, Bordas JM. Identification of factors that influence tolerance of upper gastrointestinal endoscopy. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):201-4. Davis DE, Jones MP, Kubik CM. Topical pharyngeal anesthesia does not improve upper gastrointestinal endoscopy in conscious sedated patients. Am J Gastroenterol. 1999 Jul;94(7):1853-6. Shaoul R, Higaze H, Lavy A. Evaluation of topical pharyngeal anaesthesia by benzocaine lozenge for upper endoscopy. Aliment Pharmacol Ther. 2006 Aug 15;24(4):687-94. Evans LT, Saberi S, Kim HM, Elta GH, Schoenfeld P. Pharyngeal anesthesia during sedated EGDs: is "the spray" beneficial? A meta-analysis and systematic review. Gastrointest Endosc. 2006 May;63(6):761-6. Review. Asante MA, Northfield TC. Variation in taste of topical lignocaine anaesthesia for gastroscopy. Aliment Pharmacol Ther. 1998 Jul;12(7):685-6. Mogensen S, Treldal C, Feldager E, Pulis S, Jacobsen J, Andersen O, Rasmussen M. New lidocaine lozenge as topical anesthesia compared to lidocaine viscous oral solution before upper gastrointestinal endoscopy. Local Reg Anesth. 2012;5:17-22. doi: 10.2147/LRA.S30715. Epub 2012 May 31. Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. Review. Brinklov MM. Clinical effects of carticaine, a new local anesthetic. A survey and a double-blind investigation comparing carticaine with lidocaine in epidural analgesia. Acta Anaesthesiol Scand. 1977;21(1):5-16. Kallio H, Snäll EV, Luode T, Rosenberg PH. Hyperbaric articaine for day-case spinal anaesthesia. Br J Anaesth. 2006 Nov;97(5):704-9. Epub 2006 Aug 5. Pitkänen MT, Xu M, Haasio J, Rosenberg PH. Comparison of 0.5% articaine and 0.5% prilocaine in intravenous regional anesthesia of the arm: a cross-over study in volunteers. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):131-5. Simon MA, Vree TB, Gielen MJ, Booij LH, Lagerwerf AJ. Similar motor block effects with different disposition kinetics between lidocaine and (+ or -) articaine in patients undergoing axillary brachial plexus block during day case surgery. Int J Clin Pharmacol Ther. 1999 Dec;37(12):598-607. Vree TB, Baars AM, van Oss GE, Booij LH. High-performance liquid chromatography and preliminary pharmacokinetics of articaine and its 2-carboxy metabolite in human serum and urine. J Chromatogr. 1988 Feb 26;424(2):440-4. Prout BJ, Metreweli C. Pulmonary aspiration after fibre-endoscopy of the upper gastrointestinal tract. Br Med J. 1972 Nov 4;4(5835):269-71. Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997 Dec;33(6):417-25. Review. Simon MA, Vree TB, Gielen MJ, Booij LH. Comparison of the effects and disposition kinetics of articaine and lidocaine in 20 patients undergoing intravenous regional anaesthesia during day case surgery. Pharm World Sci. 1998 Apr;20(2):88-92. Alhashemi JA. Dexmedetomidine vs midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth. 2006 Jun;96(6):722-6. Epub 2006 Apr 4.
Starting date: October 2014
Last updated: October 8, 2014
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