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

NCT02105090 | Unknown Phase 4

• 1 other identifier: 2012-005528-13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia; Hematemesis; Abdominal Pain; Heartburn

Keywords

Upper gastrointestinal tract; Endoscopy; Lozenge; Articaine; Dyspepsia; Hematemesis; Abdominal pain; Heartburn

Outcome Measures

Primary Outcomes (1)

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

  30 minutes after the procedure

Secondary Outcomes (2)

• Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS)

  within 30 minutes after the procedure

• Cumulative consumption of alfentanil during the procedure (mg)

  30 minutes after the procedure

Study Arms (3)

Sodium chloride 0.9%

PLACEBO COMPARATOR

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%

Articaine hydrochloride 1%

EXPERIMENTAL

Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy

Drug: Anesthetics, Local

Articaine hydrochloride 2%

EXPERIMENTAL

Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy

Drug: Anesthetics, Local

Interventions

Anesthetics, Local DRUG

Also known as: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08

Articaine hydrochloride 1%; Articaine hydrochloride 2%

Sodium Chloride 0.9% DRUG

Sodium chloride 0.9%

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective procedure
• weight over 40 kg
• American Society of Anesthesiology class I-III
• first upper GI endoscopy procedure
• finnish or/and swedish speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

RECRUITING

Related Publications (16)

• 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.

  PMID: 10102233 BACKGROUND

• 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.

  PMID: 10406247 BACKGROUND

• 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.

  PMID: 16907901 BACKGROUND

• 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.

  PMID: 16650534 BACKGROUND

• 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.

  PMID: 9701534 BACKGROUND

• 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.

  PMID: 22915898 BACKGROUND

• 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.

  PMID: 15966499 BACKGROUND

• 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.

  PMID: 320810 BACKGROUND

• 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.

  PMID: 16891634 BACKGROUND

• 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.

  PMID: 10204898 BACKGROUND

• 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.

  PMID: 10599952 BACKGROUND

• 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.

  PMID: 3372637 BACKGROUND

• 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.

  PMID: 4343464 BACKGROUND

• Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997 Dec;33(6):417-25. doi: 10.2165/00003088-199733060-00002.

  PMID: 9435991 BACKGROUND

• 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.

  PMID: 9584343 BACKGROUND

• 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.

  PMID: 16595611 BACKGROUND

MeSH Terms

Conditions

Dyspepsia; Hematemesis; Abdominal Pain; Heartburn

Interventions

Anesthetics, Local; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mihkel Meinberg, MD

  Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Reino Pöyhiä, MD, PhD

  Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital

  STUDY CHAIR

Central Study Contacts

Mihkel Meinberg, MD

CONTACT

+358504286766; mihkel.meinberg@hus.fi

Reino Pöyhiä, MD, PhD

CONTACT

+35894711; reino.poyhia@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 29, 2014
• First Posted: April 7, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2020
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

FI (1)