Safety and efficacy of a novel nasal spray for maxillary dental anesthesia
| Autor: | S.A. Almubarak, M.C. Hutcheson, B.D. Sobieraj, Eugene A. Pantera, Sebastian G. Ciancio, D.A. Garlapo, C.T. Pantera, F. Ayoub |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Lidocaine Tetracaine Adolescent Epinephrine medicine.drug_class medicine.medical_treatment Anesthesia Dental Oxymetazoline Placebo Injections Placebos Young Adult Double-Blind Method medicine Maxilla Humans Vasoconstrictor Agents Anesthetics Local General Dentistry Administration Intranasal Aged Pain Measurement Local anesthetic business.industry Vital Signs Nasal Sprays Middle Aged Surgery Dental anesthesia Treatment Outcome Tolerability Nasal spray Anesthesia Anesthesia Recovery Period Female Safety business medicine.drug |
| Zdroj: | Journal of dental research. 92 |
| ISSN: | 1544-0591 |
| Popis: | This study examines the efficacy, safety, and tolerability of a nasal spray to induce anesthesia of maxillary teeth. Forty-five healthy adults requiring restoration of one maxillary tooth were randomized in a 1:2 ratio to receive (1) an intra-oral lidocaine-epinephrine injection with buffered saline nasal spray bilaterally, or (2) a tetracaine hydrochloride-oxymetazoline hydrochloride nasal spray bilaterally with sham injection. Primary endpoints were use of rescue anesthesia and patient global pain assessment. Secondary outcomes included vital sign changes, soft-tissue anesthesia, and treatment-emergent adverse events. In intent-to-treat analysis, 25 of 30 patients given nasal spray (83.3%) did not require rescue anesthesia. Proportion of anesthesia successes for nasal spray was significantly different from the hypothesized placebo anesthesia success of 30% (one-sided p value < .0001 by exact binomial test). Mean duration of soft-tissue anesthesia did not differ significantly by treatment for 3 of 4 sites assessed. No serious adverse events or systemic effects were observed. Tetracaine hydrochloride-oxymetazoline nasal spray appears to provide adequate and safe anesthesia for the majority of maxillary dental procedures. Based on the results from this Phase 2 study, pivotal trials are warranted to validate these findings in an expanded patient population (ClinicalTrials.gov, NCT01302483). |
| Databáze: | OpenAIRE |
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