Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
NCT ID: NCT02105090
Last Updated: 2019-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2014-10-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Sodium Chloride 0.9%
Articaine hydrochloride 1%
Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Anesthetics, Local
Articaine hydrochloride 2%
Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Anesthetics, Local
Interventions
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Anesthetics, Local
Sodium Chloride 0.9%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* weight over 40 kg
* American Society of Anesthesiology class I-III
* first upper GI endoscopy procedure
* finnish or/and swedish speaking
Exclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Mihkel Meinberg
MD
Principal Investigators
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Mihkel Meinberg, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Reino Pöyhiä, MD, PhD
Role: STUDY_CHAIR
Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Locations
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Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
Countries
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Central Contacts
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Facility Contacts
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References
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Campo R, Brullet E, Montserrat A, Calvet X, Moix J, Rue M, Roque 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. doi: 10.1097/00042737-199902000-00023.
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. doi: 10.1111/j.1572-0241.1999.01217.x.
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. doi: 10.1111/j.1365-2036.2006.03023.x.
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. doi: 10.1016/j.gie.2005.11.059.
Asante MA, Northfield TC. Variation in taste of topical lignocaine anaesthesia for gastroscopy. Aliment Pharmacol Ther. 1998 Jul;12(7):685-6. doi: 10.1046/j.1365-2036.1998.00355.x.
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. doi: 10.1016/j.bpa.2004.12.006.
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. doi: 10.1111/j.1399-6576.1977.tb01186.x.
Kallio H, Snall EV, Luode T, Rosenberg PH. Hyperbaric articaine for day-case spinal anaesthesia. Br J Anaesth. 2006 Nov;97(5):704-9. doi: 10.1093/bja/ael222. Epub 2006 Aug 5.
Pitkanen 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. doi: 10.1016/s0378-4347(00)81126-3. No abstract available.
Prout BJ, Metreweli C. Pulmonary aspiration after fibre-endoscopy of the upper gastrointestinal tract. Br Med J. 1972 Nov 4;4(5835):269-71. doi: 10.1136/bmj.4.5835.269.
Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997 Dec;33(6):417-25. doi: 10.2165/00003088-199733060-00002.
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. doi: 10.1023/a:1008622018161.
Alhashemi JA. Dexmedetomidine vs midazolam for monitored anaesthesia care during cataract surgery. Br J Anaesth. 2006 Jun;96(6):722-6. doi: 10.1093/bja/ael080. Epub 2006 Apr 4.
Other Identifiers
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2012-005528-13
Identifier Type: -
Identifier Source: org_study_id
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