Phase 2
N=45
Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia
Dental Anesthesia Efficacy
Bottom Line
View on ClinicalTrials.gov: NCT01302483 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Pulpal Anesthesia — 25; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3% tetracaine HCL with 0.05% oxymetazoline HCL (Drug); Lidocaine Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Renatus, LLC
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulpal Anesthesia |
25; 14 | — |
| SECONDARY Soft Tissue Anesthesia Duration |
21.1; 34.2; 16.1; 32.1; 31.8; 25.0 | — |
| SECONDARY Maximum Change in Pulse From Baseline |
-11.13; -6.60 | — |
| SECONDARY Maximum Change in Blood Pressure From Baseline |
4.50; 3.43; -2.67; -5.07 | — |
| SECONDARY Maximum Change in Pulse Oximetry From Baseline |
0.17; -0.80 | — |
Summary
The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.
Eligibility Criteria
Inclusion Criteria
- Male or female between 18 and 65 years of age
- Sufficiently healthy as determined by the investigator to receive the test and control medications and undergo the scheduled dental procedure
- Required an operative restorative procedure on a single maxillary tooth, other than a maxillary second or third molar, with treatment time not expected to exceed 60 minutes
- Could breathe through both nostrils
- Had normal lip, nose, eyelid, and cheek sensations
- Could understand and sign the informed consent document
- Could communicate with the investigator
- Could understand and comply with the requirements of the protocol
Exclusion Criteria
- Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal, neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of angle-closure glaucoma
- Clinically relevant sinus/nasal surgical history
- Baseline Visual Analog Scale value of > 36 (or greater than weak) at the treatment site
- Had not had dental work requiring a local anesthetic within the last 24 hours or had taken pain medications within the last 48 hours
- Required prophylactic antibiotics for subacute bacterial endocarditis (infectious endocarditis)
- Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or p-aminobenzoic acid (PABA), as found in PABA-containing sunscreens
- Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their solutions
- Had a current condition, such as nasal congestion or sinus infection, that may have influenced responses to study medications
- History of alcoholism and/or drug abuse
- Had taken a monamine oxidase inhibitor within the past 3 weeks
- Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant (females were required to take a urine pregnancy test to rule out pregnancy)
- Had used any investigational drug and/or participated in any clinical trial within 30 days of baseline
Data sourced from ClinicalTrials.gov (NCT01302483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.