Abdominal Pain Clinical Trial
Official title:
Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital | Helsinki | Uusimaa |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital |
Finland,
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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. — View Citation
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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. — View 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. — View Citation
Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997 Dec;33(6):417-25. Review. — View Citation
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. — View Citation
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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. — View 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. — View 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. — View Citation
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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. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS) | within 30 minutes after the procedure | ||
Secondary | Cumulative consumption of alfentanil during the procedure (mg) | 30 minutes after the procedure |
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