The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.

Start Date01 Sep 2020

Sponsor / Collaborator

Virginia Commonwealth University

NCT04105985 / WithdrawnPhase 2IIT

Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial

Start Date01 Aug 2020

Sponsor / Collaborator

Virginia Commonwealth University

NCT03962634 / TerminatedPhase 2IIT

Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial

Start Date28 Aug 2019

Sponsor / Collaborator

Virginia Commonwealth University

100 Clinical Results associated with Oxymetazoline Hydrochloride/Tetracaine Hydrochloride

100 Translational Medicine associated with Oxymetazoline Hydrochloride/Tetracaine Hydrochloride

100 Patents (Medical) associated with Oxymetazoline Hydrochloride/Tetracaine Hydrochloride

Literatures (Medical) associated with Oxymetazoline Hydrochloride/Tetracaine Hydrochloride

01 Apr 2022·Anesthesia Progress

Kovanaze Intranasal Spray vs Traditional Injected Anesthetics: a Study of Pulpal Blood Flow Utilizing Laser Doppler Flowmetry

Article

Author: Odom, Mark ; Thayer, Scott ; Peters, Mathilde ; Sabey, Kent A. ; Yu, Qingzhao ; Townsend, Janice A.

Objective:An ideal local anesthetic would be effective, minimally reduce pulpal blood flow (PBF), and not require injection. This study compared the effects of 3% tetracaine plus 0.05% oxymetazoline nasal spray (Kovanaze; KNS) and injections using 2% lidocaine with 1:100,000 epinephrine (LE) or 3% mepivacaine plain (MP) on PBF, anesthetic efficacy, and participant preference.Methods:In a double-blind cross-over design, 20 subjects randomly received a test anesthetic and placebo at each of 3 visits (KNS/mock infiltration; mock nasal spray/LE; or mock nasal spray/MP). Nasal sprays and infiltration apical to a maxillary central incisor were delivered ipsilaterally. PBF was evaluated by laser Doppler flowmetry, and local anesthetic success was assessed with electric pulp testing. Postoperative pain levels, participant preference, and adverse events were also assessed.Results:LE injections demonstrated significant reductions in PBF at all time intervals compared with baseline (P < .05), whereas KNS and MP did not. Pulpal anesthesia success rates were higher for LE (85%) compared with MP (35%) and KNS (5%). Participants reported significantly higher postoperative pain levels for KNS compared with LE and MP. Additionally, KNS was the least preferred of the anesthetics administered and resulted in more reported adverse events.Conclusion:Although KNS showed no significant effect on PBF, it was not effective in achieving pulpal anesthesia as used in this study.

01 Mar 2019·Journal of EndodonticsQ2 · MEDICINE

Anesthetic Efficacy of Intranasal 3% Tetracaine plus 0.05% Oxymetazoline (Kovanaze) in Maxillary Teeth

Q2 · MEDICINE

Article

Author: Drum, Melissa ; Capetillo, Jeremy ; Nusstein, John ; Reader, Al ; Fowler, Sara ; Beck, Mike

INTRODUCTIONNeedle-free anesthetic delivery is a promising alternative to traditional anesthetic routes of administration. The purpose of this study was to determine the patient preference for and pulpal anesthetic efficacy of a 3% tetracaine plus 0.05% oxymetazoline (Kovanaze) nasal spray in maxillary lateral incisors and first premolars.METHODSFifty adult subjects randomly received a 3% tetracaine plus 0.05% oxymetazoline (Kovanaze) nasal spray and mock infiltration or a mock nasal spray and 2% lidocaine with 1:100,000 epinephrine infiltration at the maxillary lateral incisor or first premolar in 2 appointments spaced at least 1 week apart in a single-blind cross-over design. Pulpal anesthesia was evaluated with an electric pulp tester. Side effects and subject preferences were also recorded.RESULTSAnesthetic success was significantly lower for the Kovanaze nasal spray and mock infiltration (22%-37%) than for the mock nasal spray and lidocaine infiltration (89%-91%). Subjects reported more unwanted effects (nasal drainage and congestion, burning, pressure, and sinus congestion) after the Kovanaze nasal spray and mock infiltration than the mock spray and maxillary infiltration. Before participating in the study, more subjects (56%) preferred the nasal spray route versus a standard infiltration (44%). After experiencing both routes of administration, 100% of subjects preferred the standard infiltration.CONCLUSIONSThe 3% tetracaine plus 0.05% oxymetazoline (Kovanaze) nasal spray provided significantly less successful pulpal anesthesia than the lidocaine infiltration, was less preferable, and caused more unwanted effects.

100 Deals associated with Oxymetazoline Hydrochloride/Tetracaine Hydrochloride

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R&D Status

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Indication	Country/Location	Organization	Date
Anesthesia	US	St. Renatus LLC	29 Jun 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03962634 (CTgov)	Phase 2	Periapical Periodontitis \| Dental Caries	3	Kovanaze Nasal Spray (Kovanaze Nasal Spray (Pediatrics))	gandufrhqy(bvwptxjyvv) = ufkmbsxhkp hixonxjfhh (wdwcteolnc, ttzrvkbrit - oznggntqkt) View more	-	19 Nov 2020
				Articaine Injection (Articaine Injections (Pediatrics))	gandufrhqy(bvwptxjyvv) = ybcnwsgwtf hixonxjfhh (wdwcteolnc, epkovnrwlt - ntnxhozvfg) View more
NCT01701505 (CTgov)	Phase 2	Anesthesia	48	400uL of Kovacaine Mist (Kovacaine Mist High Dose)	asxwahbspd(xevklvmpcy) = qszdmovebo jtypfbqzbv (ilmkujbgpr, bygytrdpls - zqktpfmwfg) View more	-	30 Aug 2017
				200uL of Kovacaine Mist (Kovacaine Mist Mid Dose)	tikfuqzoif(usxeikonzd) = gayzprstil vwmqkklfgr (rnvpavwejq, rgobrawyty - wgafouzmdw) View more
NCT01479517 (CTgov)	Phase 2	Anesthesia	30	Kovacaine Mist 0.1 mL x 4 sprays (Kovacaine Mist 0.1 mL x 4 Sprays)	tchcthbyqf(sfyyqsyieq) = embqfoxcbl pwyhjgymsd (yqhhfeganb, ursdfbzwxx - ksirniqdfh) View more	-	29 Dec 2016
				Kovacaine Mist 0.2 mL x 2 sprays (Kovacaine Mist 0.2 mL x 2 Sprays)	tchcthbyqf(sfyyqsyieq) = apjkmobwrb pwyhjgymsd (yqhhfeganb, frnxuunhqr - crvlvwwqvo) View more

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