Back to resultsEfficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
Primary Purpose
Dyspepsia, Hematemesis, Abdominal Pain
Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Anesthetics, Local
Sodium Chloride 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring Upper gastrointestinal tract, Endoscopy, Lozenge, Articaine, Dyspepsia, Hematemesis, Abdominal pain, Heartburn
Eligibility 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
Sites / Locations
- Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Sodium chloride 0.9%
Articaine hydrochloride 1%
Articaine hydrochloride 2%
Arm Description
Sodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Outcomes
Primary Outcome Measures
Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale).
Secondary Outcome Measures
Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS)
Cumulative consumption of alfentanil during the procedure (mg)
Full Information
NCT ID
NCT02105090
First Posted
March 29, 2014
Last Updated
May 3, 2019
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02105090
Brief Title
Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
Official Title
Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Hematemesis, Abdominal Pain, Heartburn
Keywords
Upper gastrointestinal tract, Endoscopy, Lozenge, Articaine, Dyspepsia, Hematemesis, Abdominal pain, Heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sodium chloride 0.9%
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Arm Title
Articaine hydrochloride 1%
Arm Type
Experimental
Arm Description
Articaine hydrochloride 1% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Arm Title
Articaine hydrochloride 2%
Arm Type
Experimental
Arm Description
Articaine hydrochloride 2% flavoured lozenge 10 ml administered orally (gargled and swallowed by patient) 3 minutes before the upper GI endoscopy
Intervention Type
Drug
Intervention Name(s)
Anesthetics, Local
Other Intervention Name(s)
Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9%
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS)
Time Frame
within 30 minutes after the procedure
Title
Cumulative consumption of alfentanil during the procedure (mg)
Time Frame
30 minutes after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mihkel Meinberg, MD
Phone
+358504286766
Email
mihkel.meinberg@hus.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Reino Pöyhiä, MD, PhD
Phone
+35894711
Email
reino.poyhia@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihkel Meinberg, MD
Organizational Affiliation
Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reino Pöyhiä, MD, PhD
Organizational Affiliation
Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihkel Meinberg, MD
Phone
+358504286766
Email
mihkel.meinberg@hus.fi
First Name & Middle Initial & Last Name & Degree
Reino Pöyhiä, MD, PhD
Phone
+35894711
Email
reino.poyhia@hus.fi
First Name & Middle Initial & Last Name & Degree
Mihkel Meinberg, MD
First Name & Middle Initial & Last Name & Degree
Kalle Jokelainen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Harri Mustonen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hannamari Hakojärvi, Pharm.D
First Name & Middle Initial & Last Name & Degree
Anne Juppo, Pharm.D, PhD
First Name & Middle Initial & Last Name & Degree
Pertti Pere, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
10102233
Citation
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.
Results Reference
background
PubMed Identifier
10406247
Citation
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.
Results Reference
background
PubMed Identifier
16907901
Citation
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.
Results Reference
background
PubMed Identifier
16650534
Citation
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.
Results Reference
background
PubMed Identifier
9701534
Citation
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.
Results Reference
background
PubMed Identifier
22915898
Citation
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.
Results Reference
background
PubMed Identifier
15966499
Citation
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.
Results Reference
background
PubMed Identifier
320810
Citation
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.
Results Reference
background
PubMed Identifier
16891634
Citation
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.
Results Reference
background
PubMed Identifier
10204898
Citation
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.
Results Reference
background
PubMed Identifier
10599952
Citation
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.
Results Reference
background
PubMed Identifier
3372637
Citation
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.
Results Reference
background
PubMed Identifier
4343464
Citation
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.
Results Reference
background
PubMed Identifier
9435991
Citation
Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997 Dec;33(6):417-25. doi: 10.2165/00003088-199733060-00002.
Results Reference
background
PubMed Identifier
9584343
Citation
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.
Results Reference
background
PubMed Identifier
16595611
Citation
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.
Results Reference
background
Learn more about this trial
Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
We'll reach out to this number within 24 hrs