The cardiovascular effects and pharmacokinetics of intranasal tetracaine plus oxymetazoline

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.

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“…This study found that the product was well-tolerated in study participants with no serious sideeffects (Giannakopoulos et al, 2012) …”

Section: Discussionmentioning

confidence: 70%

Safety and Efficacy of a Novel Nasal Spray for Maxillary Dental Anesthesia

et al. 2013

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“…Past studies typically were performed in periprocedural settings, lacked a placebo group, and compared patient hemodynamics before and after administration as a secondary objective (15, 16, 18, 19, 34, 35). These study designs may be confounded by concurrent medications and procedures, particularly in the case of nasal intubation, which independently can produce hypertension (16, 20).…”

Section: Discussionmentioning

confidence: 99%

Effect of Intranasal Vasoconstrictors on Blood Pressure: A Randomized, Double-Blind, Placebo-Controlled Trial

Nichols

et al. 2018

The Journal of Emergency Medicine

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Background: Treatment for epistaxis includes application of intranasal vasoconstrictors. These medications have a precaution against use in patients with hypertension. Given that many patients who present with epistaxis are hypertensive, these warnings are commonly overridden by clinical necessity. Objectives: To determine the effects of these medications on blood pressure. Methods: We conducted a single-center, randomized, double-blind, placebo-controlled trial from November 2014 through July 2016. Adult patients being discharged from the emergency department (ED) at Mayo Clinic (Rochester, Minnesota) were recruited. Patients were ineligible if they had a contraindication to study medications, had a history of hypertension, were currently taking antihypertensive or antiarrhythmic medications, or had nasal abnormalities such as epistaxis. Subjects were randomized to 1 of 4 study arms (phenylephrine 0.25%; oxymetazoline 0.05%; lidocaine 1% with epinephrine 1:100,000; or bacteriostatic 0.9% sodium chloride [saline]). Blood pressure and heart rate were measured every 5 minutes for 30 minutes. Results: Sixty-eight patients were enrolled in the study; of these, 63 patients completed the study (oxymetazoline, n=15; phenylephrine, n=20; lidocaine with epinephrine, n=11; saline, n=17). We did not observe any significant differences in mean arterial pressure over time between phenylephrine and saline, oxymetazoline and saline, or lidocaine with epinephrine and saline. The mean greatest increases from baseline in mean arterial pressure, systolic and diastolic blood pressure, and heart rate for each treatment group also were not significantly different from the saline group. Conclusion: Intranasal vasoconstrictors did not significantly increase blood pressure in patients without a history of hypertension. Our findings reinforce the practice of administering these medications to patients who present to the ED with epistaxis, regardless of high blood pressure.

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“…TTC is a member of the ester class of local anesthetics that is used to anesthetize nasal tissues before diagnostic and surgical procedures [77]. Lima et al [39] evaluated the antinociceptive effect induced by TTC complexes through the infraorbital nerve blockade test in rats and showed that the complexation with HPbCD and bCD increased the analgesic duration and intensity induced by TTC alone.…”

Section: Other Analgesic Drugsmentioning

confidence: 99%