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1.
Dermatol Ther ; 35(4): e15327, 2022 04.
Article in English | MEDLINE | ID: mdl-35060229

ABSTRACT

Persistent post acne erythema (PAE) is common cosmetically unacceptable and challenging sequelae of acne lesions. Tranexamic acid (TXA) is an antifibrinolytic agent that shows a positive effect on wound healing in several studies, and it showed benefits in treating skin diseases like melasma, rosacea erythema and ultraviolet induced pigmentations. Oxymetazoline (OXZ) is a synthetic, highly selective agonist for alpha 1A-adrenoceptor. It is a potent vasoconstrictor. OXZ hydrochloride 1% cream was approved by the FDA in January 2017 as a topical treatment for persistent facial erythema in rosacea patients. Brimonidine tartrate (BMT) is highly selective α2 adrenergic receptor agonist, results in direct, potent vasoconstriction of small arterioles and veins. In 2013, brimonidine 0.33% gel was the first topical therapy to be FDA approved for the treatment of persistent facial erythema from rosacea. To evaluate the efficacy and safety of topical triple combination (TXA 5% + OXZ 1.5% + BMT 0.33%) in the treatment of PAE planned as split face comparative study. This study was conducted on 40 patients diagnosed with persistent PAE for at least 3 months, the right side of the face was treated with topical triple combination in liposomal base and was compared to the left side to which topical lipocream (placebo) was applied as a control. Our treatment plan lasted for 3 months. According to the investigator's global assessment of photographs and computerized analysis of erythema using image analysis software, topical triple combination applied on the right side of face was significantly effective in diminishing PAE when compared to topical placebo left side. Topical triple combination is a safe and cost-effective treatment for PAE.


Subject(s)
Acne Vulgaris , Erythema , Acne Vulgaris/complications , Acne Vulgaris/drug therapy , Administration, Topical , Brimonidine Tartrate/administration & dosage , Drug Therapy, Combination/adverse effects , Erythema/drug therapy , Erythema/etiology , Humans , Oxymetazoline/administration & dosage , Rosacea/drug therapy , Treatment Outcome
2.
J Dermatolog Treat ; 33(2): 904-909, 2022 Mar.
Article in English | MEDLINE | ID: mdl-32602755

ABSTRACT

BACKGROUND: Post-inflammatory erythema (PIE) is a common sequalae of acne inflammation, persistent post acne erythema (PAE) is cosmetically unacceptable and sometimes its complete clearance could not be achieved. Oxymetazoline (OXZ) is a synthetic, direct-acting, sympathomimetic agonist that is highly selective for the 1α-adrenoceptor. It is a potent vasoconstrictor and well known for its ability to clinically 'get the red out'. AIM: The aim of this study was to evaluate the efficacy and safety of topical oxymetazoline (OXZ) 1.5% in treatment of post acne erythema (PAE) in a left to right face comparative study. METHODS: This study was conducted on 40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with topical OXZ 1.5% in liposomal base and was compared to the right side to which topical lipogel was applied as a control. RESULTS: According to the investigator's global assessment of photographs and the analysis of erythema with image analysis software, topical OXZ was significantly effective in diminishing PAE when compared to topical placebo lipogel. CONCLUSION: Topical OXZ is a safe and effective treatment for post-acne erythema.


Subject(s)
Acne Vulgaris , Oxymetazoline , Administration, Topical , Adrenergic alpha-Agonists/therapeutic use , Erythema/diagnosis , Erythema/drug therapy , Erythema/etiology , Face , Humans , Oxymetazoline/administration & dosage , Oxymetazoline/adverse effects , Treatment Outcome
3.
J Laryngol Otol ; 136(1): 8-16, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34702392

ABSTRACT

OBJECTIVE: This study aimed to summarise the evidence for efficacy of combination treatment of intranasal corticosteroid spray with oxymetazoline hydrochloride nasal spray for chronic rhinitis. METHOD: Nine databases were systematically searched from study inception in September 2016 to 1 June 2020. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was followed. RESULTS: A total of 130 studies were screened, and 4 randomised controlled trials comprising 838 patients met inclusion criteria. The study found superior improvement of nasal congestion from onset of treatment to completion in intranasal corticosteroid spray and oxymetazoline hydrochloride groups compared with control groups. Intranasal corticosteroid spray and oxymetazoline hydrochloride use resulted in higher nasal volume (standard error of mean 1, 15.8 + 1.1 ml; p < .03) compared with either placebo (12.1 + 0.9 ml) or oxymetazoline hydrochloride (12.4 + 0.8 ml) alone (p = 0.003). CONCLUSION: Intranasal corticosteroid spray and oxymetazoline hydrochloride combination treatment may be superior in reducing rhinitis symptoms compared with either intranasal corticosteroid spray or oxymetazoline hydrochloride alone, without inducing rhinitis medicamentosa.


Subject(s)
Glucocorticoids/administration & dosage , Nasal Decongestants/administration & dosage , Oxymetazoline/administration & dosage , Rhinitis/drug therapy , Administration, Intranasal , Chronic Disease , Humans
4.
Ann Otol Rhinol Laryngol ; 131(1): 59-70, 2022 Jan.
Article in English | MEDLINE | ID: mdl-33840220

ABSTRACT

OBJECTIVES: Topical vasoconstrictors and intravenous tranexamic acid (IV TXA) are safe and efficacious to decrease bleeding and improve the surgical field during endoscopic sinus surgery (ESS). The purpose of this study was to investigate practice patterns, awareness of clinical evidence, and comfort levels among anesthesia providers regarding these hemostatic agents for ESS. METHODS: A total of 767 attending anesthesiologists, residents, and certified registered nurse anesthetists (CRNAs) at 5 United States academic centers were invited to participate in a survey regarding their experience with IV TXA and 3 topical vasoconstrictor medications (oxymetazoline, epinephrine, and cocaine) during ESS. RESULTS: 330 (47%) anesthesia providers responded to the electronic survey. 113 (97%) residents, 92 (83%) CRNAs, and 52 (68%) attendings managed 5 or fewer ESS cases per month. Two-thirds of providers had not reviewed efficacy or safety literature for these hemostatic agents. Oxymetazoline was perceived safest, followed by epinephrine, IV TXA, and cocaine. Respondents considered potential side effects over surgical field visibility when selecting agents. The majority of providers had no formal training on these agents for ESS, but indicated interest in educational opportunities. CONCLUSION: Many anesthesia providers are unfamiliar with safety and efficacy literature regarding agents used to improve hemostasis for ESS, highlighting a need for development of relevant educational resources. Rhinologic surgeons have an opportunity to communicate with anesthesia colleagues on the use of hemostatic agents to improve the surgical field during ESS.


Subject(s)
Anesthesiology , Antifibrinolytic Agents/administration & dosage , Endoscopy , Paranasal Sinuses/surgery , Practice Patterns, Physicians' , Tranexamic Acid/administration & dosage , Vasoconstrictor Agents/administration & dosage , Administration, Intravenous , Administration, Topical , Cocaine/administration & dosage , Epinephrine/administration & dosage , Health Care Surveys , Humans , Otorhinolaryngologic Surgical Procedures/methods , Oxymetazoline/administration & dosage
5.
Pediatrics ; 148(5)2021 11 01.
Article in English | MEDLINE | ID: mdl-34607935

ABSTRACT

The over-the-counter nasal decongestant oxymetazoline (eg, Afrin) is used in the pediatric population for a variety of conditions in the operating room setting. Given its vasoconstrictive properties, it can have cardiovascular adverse effects when systemically absorbed. There have been several reports of cardiac and respiratory complications related to use of oxymetazoline in the pediatric population. Current US Food and Drug Administration approval for oxymetazoline is for patients ≥6 years of age, but medical professionals may elect to use it short-term and off label for younger children in particular clinical scenarios in which the potential benefit may outweigh risks (eg, active bleeding, acute respiratory distress from nasal obstruction, acute complicated sinusitis, improved surgical visualization, nasal decongestion for scope examination, other conditions, etc). To date, there have not been adequate pediatric pharmacokinetic studies of oxymetazoline, so caution should be exercised with both the quantity of dosing and the technique of administration. In the urgent care setting, emergency department, or inpatient setting, to avoid excessive administration of the medication, medical professionals should use the spray bottle in an upright position with the child upright. In addition, in the operating room setting, both monitoring the quantity used and effective communication between the surgeon and anesthesia team are important. Further studies are needed to understand the systemic absorption and effects in children in both nonsurgical and surgical nasal use of oxymetazoline.


Subject(s)
Nasal Decongestants/adverse effects , Oxymetazoline/adverse effects , Perioperative Care , Age Factors , Child , Child, Preschool , Female , Heart Rate/drug effects , Humans , Hypertension/chemically induced , Intraoperative Complications/chemically induced , Male , Nasal Decongestants/administration & dosage , Nasal Decongestants/pharmacokinetics , Off-Label Use , Operating Rooms , Oxymetazoline/administration & dosage , Oxymetazoline/pharmacokinetics
6.
Undersea Hyperb Med ; 48(2): 149-152, 2021.
Article in English | MEDLINE | ID: mdl-33975404

ABSTRACT

Middle ear barotrauma (MEB) is a common complication of hyperbaric oxygen (HBO2) therapy. It has been reported in more than 40% of HBO2 treatments and can interrupt the sequence of HBO2. MEB may lead to pain, tympanic membrane rupture, and even hearing loss. The aim of this study was to determine if pretreatment with intranasal fluticasone and oxymetazoline affected the incidence of MEB. We conducted a retrospective chart review of subjects undergoing HBO2 at our institution between February 1, 2014, and May 31, 2019. Subjects in the fluticasone/oxymetazoline (FOT) treatment group used intranasal fluticasone 50 mcg two times per day and oxymetazoline 0.05% one spray two times per day beginning 48 hours prior to initial HBO2. Oxymetazoline was discontinued after four days. Fluticasone was continued for the duration of HBO2 therapy. A total of 154 unique subjects underwent 5,683 HBO2 treatments: 39 unique subjects in the FOT group underwent 1,501 HBO2; 115 unique subjects in the nFOT (no oxymetazoline or fluticasone treatment) group underwent 4,182 HBO2 treatments. The incidence of MEB was 15.4% in the FOT group and 16.2% in the nFOT group. This was not a statistically significant difference (OR = 0.77; p = 0.636). Treatment pressure, age over 65 years, male sex, and BMI were not associated with a difference in MEB incidence. In summary, pretreatment with intranasal oxymetazoline and fluticasone in patients undergoing HBO2 did not significantly reduce MEB. More investigation with larger numbers of participants and prospective studies could further clarify this issue.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Barotrauma/prevention & control , Ear, Middle/injuries , Fluticasone/therapeutic use , Hyperbaric Oxygenation/adverse effects , Nasal Decongestants/therapeutic use , Oxymetazoline/therapeutic use , Administration, Intranasal , Aged , Anti-Inflammatory Agents/administration & dosage , Barotrauma/epidemiology , Barotrauma/etiology , Drug Administration Schedule , Female , Fluticasone/administration & dosage , Humans , Incidence , Male , Middle Aged , Nasal Decongestants/administration & dosage , Nasal Sprays , Oxymetazoline/administration & dosage , Retrospective Studies
8.
JAMA Ophthalmol ; 138(11): 1168-1175, 2020 11 01.
Article in English | MEDLINE | ID: mdl-33001144

ABSTRACT

Importance: Treatment of acquired blepharoptosis (ptosis) is currently limited to surgical intervention. Objective: To examine the efficacy and safety of oxymetazoline hydrochloride, 0.1%, ophthalmic solution (oxymetazoline, 0.1%) in participants with acquired ptosis. Design, Setting, and Participants: This pooled analysis of 2 randomized, double-masked, placebo-controlled, multicenter phase 3 clinical trials included participants 9 years and older with acquired ptosis and superior visual field deficit. The 2 studies were conducted across 16 and 27 sites in the United States. Patients were enrolled from May 2015 to April 2019. Analyses for the individual trials were initiated after database lock and completed on September 6, 2017, and May 16, 2019. Pooled analysis was completed on August 25, 2019. Interventions: Participants (randomized 2:1) received oxymetazoline, 0.1%, or vehicle, self-administered as a single drop per eye, once daily, for 42 days. Main Outcomes and Measures: The primary efficacy end point was change from baseline in the number of points seen on the Leicester Peripheral Field Test, a test to detect superior visual field deficits due to ptosis, on days 1 (6 hours after instillation) and 14 (2 hours after instillation). The secondary end point, change from baseline in marginal reflex distance 1, was assessed at the same time points. Results: In total, 304 participants were enrolled (mean [SD] age, 63.8 [13.8] years; 222 women [73%]). Overall, 97.5% (198 of 203) of participants receiving oxymetazoline, 0.1%, and 97.0% (98 of 101) of participants receiving vehicle completed the studies. Oxymetazoline, 0.1%, was associated with a significant increase in the mean (SD) number of points seen on the Leicester Peripheral Field Test vs vehicle (day 1: 5.9 [6.4] vs 1.8 [4.1]; mean difference, 4.07 [95% CI, 2.74-5.39]; P < .001; day 14: 7.1 [5.9] vs 2.4 [5.5]; mean difference, 4.74 [95% CI, 3.43-6.04]; P < .001). Oxymetazoline, 0.1%, also was associated with a significant increase in marginal reflex distance 1 from baseline (mean [SD]: day 1: 0.96 [0.89] mm vs 0.50 [0.81] mm; mean difference, 0.47 mm [95% CI, 0.27-0.67]; P < .001; day 14: 1.16 [0.87] mm vs 0.50 [0.80] mm; mean difference, 0.67 mm [95% CI, 0.46-0.88]; P < .001). Treatment-emergent adverse events (TEAEs) occurred in 31.0% (63 of 203) of participants receiving oxymetazoline, 0.1%, and 35.6% (36 of 101) of participants receiving vehicle. Among participants receiving oxymetazoline, 0.1%, with a TEAE, 81% (51 of 63) had a maximum TEAE intensity of mild, and 62% (39 of 63) had no TEAE suspected of being treatment related. Conclusions and Relevance: Oxymetazoline, 0.1%, was associated with positive outcomes and was well tolerated in phase 3 trials after instillation at days 1 and 14, demonstrating its potential promise for the treatment of acquired ptosis, although further study is needed to elucidate the clinical relevance of these findings beyond 6 weeks.


Subject(s)
Blepharoptosis/drug therapy , Oxymetazoline/administration & dosage , Visual Fields/drug effects , Adolescent , Adrenergic alpha-Agonists/administration & dosage , Adult , Aged , Aged, 80 and over , Blepharoptosis/physiopathology , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Male , Middle Aged , Ophthalmic Solutions , Treatment Outcome , Young Adult
9.
Clin Med Res ; 18(2-3): 99-101, 2020 08.
Article in English | MEDLINE | ID: mdl-32816989

ABSTRACT

Hemolacria is a rare complication of epistaxis treated with nasal compression or tamponade. We report the case of a man, aged 81 years, with end-stage renal disease who developed hemolacria after insertion of a "Rhino Rocket" nasal tamponade device to treat persistent epistaxis. The hemolacria resolved after treatment with intranasal oxymetazoline. In the setting of epistaxis with nasal tamponade, hemolacria is thought to be caused by retrograde flow from the inferior nasal turbinates via an anatomic connection with the lacrimal system, with passage through the valves of Hasner and Rosenmüller to the lacrimal ducts. Hemolacria is very rare even in severe cases of epistaxis; we postulate that only patients with either congenital absence or acquired incompetence of the lacrimal valves are predisposed to hemolacria after treatment of epistaxis with a tamponade device. Physicians should be aware that hemolacria in the setting of epistaxis is usually a self-limited condition that can be treated with conservative measures to control nasal hemorrhage.


Subject(s)
Epistaxis , Kidney Failure, Chronic , Oxymetazoline/administration & dosage , Tampons, Surgical , Administration, Intranasal , Aged, 80 and over , Epistaxis/etiology , Epistaxis/therapy , Humans , Kidney Failure, Chronic/complications , Kidney Failure, Chronic/therapy , Male
10.
BMC Res Notes ; 13(1): 236, 2020 May 01.
Article in English | MEDLINE | ID: mdl-32357900

ABSTRACT

OBJECTIVES: The study aimed to determine the effect of oxymetazoline nasal spray on the patency of the fistula created after dacryocystorhinostomy, specifically: to compare the success of fistula formation with oxymetazoline versus placebo, and to compare the incidence of post-operative congestion, pain and bleeding with oxymetazoline versus placebo. RESULTS: The study was a single-center, randomized controlled, triple-masked study involving the patients of the Plastic-Lacrimal service of a national university hospital. Block randomization was done. Dacryocystorhinostomy was performed by a single-masked surgeon. The intervention group used oxymetazoline. The placebo group used sodium chloride. The data were collected by another masked investigator. The study showed no significant difference in terms of congestion, pain and epistaxis between the two groups at day 2 post-operation. The patency, presence of silicone tube, granuloma formation, and presence of bleeding on both day 2 and day 16 post-operation had no difference between the two groups. This study doesn't support the use of oxymetazoline nasal spray after DCR, since it does not decrease the symptoms of congestion, pain and epistaxis after DCR. Aside from being an additional expense for patients, it also does not affect fistula formation and success rate of the surgery. Trial registration Australian New Zealand Clinical Trial Registry: ACTRN12619001394134, Date registered 10/11/2019, Retrospectively Registered.


Subject(s)
Dacryocystorhinostomy , Epistaxis/drug therapy , Fistula/drug therapy , Nasal Decongestants/pharmacology , Outcome Assessment, Health Care , Oxymetazoline/pharmacology , Pain, Postoperative/drug therapy , Postoperative Complications/drug therapy , Adult , Aged , Dacryocystorhinostomy/adverse effects , Double-Blind Method , Epistaxis/etiology , Female , Fistula/etiology , Humans , Male , Middle Aged , Nasal Decongestants/administration & dosage , Nasal Sprays , Oxymetazoline/administration & dosage , Pain, Postoperative/etiology , Postoperative Complications/etiology , Sodium Chloride/pharmacology
11.
Ear Nose Throat J ; 99(1_suppl): 30S-34S, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32182136

ABSTRACT

OBJECTIVES: Only a few medications have a United States Food and Drug Administration indications for prevention and/or treatment of infections in patients with tympanic perforations or tympanostomy tubes. We examined 3 off-label agents that have become important in tympanostomy tube care hoping to demonstrate the effectiveness and safety of each in experimental assays and human application. METHODS: Computerized literature review. RESULTS: (1) Oxymetazoline nasal spray applied at the time of surgery is equivalent to fluoroquinolone ear drops in the prevention of early postsurgical otorrhea and tympanostomy tube occlusion at the first postoperative visit. (2) Topical mupirocin 2% ointment is effective alone or in combination with culture-directed systemic therapy for the treatment of tympanostomy tube otorrhea caused by community-acquired, methicillin-resistant Staphylococcus aureus. (3) Topical clotrimazole 1% cream is highly active against the common yeast and fungi that cause otomycosis. A single application after microscopic debridement will cure fungal tympanostomy tube otorrhea in most cases. None of these 3 agents is ototoxic in animal histological or physiological studies, and each has proved safe in long-term clinical use. CONCLUSIONS: Oxymetazoline nasal spray, mupirocin ointment, and clotrimazole cream are safe and effective as off-label medications for tympanostomy tube care in children.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Antibiotic Prophylaxis/methods , Middle Ear Ventilation/adverse effects , Otitis Media with Effusion/surgery , Otitis/prevention & control , Prosthesis-Related Infections/prevention & control , Administration, Topical , Child , Child, Preschool , Clotrimazole/administration & dosage , Female , Humans , Male , Methicillin-Resistant Staphylococcus aureus , Mupirocin/administration & dosage , Nasal Sprays , Off-Label Use , Otitis/microbiology , Otitis Media with Effusion/microbiology , Oxymetazoline/administration & dosage , Prosthesis-Related Infections/microbiology , Staphylococcal Infections/microbiology , Staphylococcal Infections/prevention & control
13.
J Emerg Med ; 58(2): 211-216, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31899024

ABSTRACT

BACKGROUND: The use of tranexamic acid (TXA) has recently gained popularity as a treatment modality for epistaxis in the emergency department. Previous studies have compared topical TXA to nasal packing. However, topical TXA has not yet been compared with topical oxymetazoline in the treatment of epistaxis. OBJECTIVES: This study compares the efficacy of the intravenous formulation of TXA applied topically vs. the vasoconstrictor oxymetazoline applied topically in achieving hemostasis in patients presenting to the emergency department with anterior epistaxis. METHODS: In this prospective study, patients presenting to the emergency department with the chief complaint of epistaxis, and meeting inclusion criteria, were allocated into 2 treatment groups; topical oxymetazoline vs. topical application of the intravenous preparation of TXA. Patients were assessed for time to hemostasis in the emergency department as well as the occurrence of rebleeding within the next 48 h after discharge. RESULTS: Hemostasis was achieved in 14 (78%) of the 18 patients in the TXA group compared with 7 (35%) of the 20 patients in the oxymetazoline group. While there were occurrences of rebleeding in the emergency department before discharge and at 48 h in both groups, 11 patients in the TXA group had no recurrence of bleeding compared with 5 in the oxymetazoline group. CONCLUSION: This study demonstrated that the topical application of the intravenous preparation of TXA is more effective than topical oxymetazoline for achievement of hemostasis in anterior epistaxis. This has clinical significance toward preventing an avoidable need for escalation of treatment that could include applying nasal packing or cautery as well as preventing avoidable return emergency department visits. These outcomes would increase cost, potentially increase patient discomfort, and prolong emergency department throughput time.


Subject(s)
Epistaxis/drug therapy , Hemostasis , Oxymetazoline/administration & dosage , Sympathomimetics/administration & dosage , Tranexamic Acid/administration & dosage , Administration, Topical , Aged , Antifibrinolytic Agents , Emergency Service, Hospital , Female , Humans , Male , Prospective Studies , Single-Blind Method
14.
Can J Ophthalmol ; 54(4): 513-516, 2019 08.
Article in English | MEDLINE | ID: mdl-31358153

ABSTRACT

OBJECTIVE: Subconjunctival hemorrhage (SCH) is an important minor side effect that might affect patient compliance to antivascular endothelial growth factor (anti-VEGF) intravitreal injection treatment (IVI). We sought to compare SCH incidence and pain score responses after topical oxymetazoline in naïve patients undergoing a single IVI of ranibizumab for diabetic macular edema. METHODS: Prospective, randomized, double-blinded, single centre study. One hundred two patients naïve to anti-VEGF were assigned to receive either topical oxymetazoline or placebo 30 minutes before IVI. SCH incidence and area were measured by slit lamp 24 hours after, and pain was evaluated 5 minutes and 24 hours after. RESULTS: SCH incidence was reported on 72% in control group versus 51% in oxymetazoline group (p = 0.037). Mean size of SCH was 16.82 mm2 in control group versus 12.55 mm2 in oxymetazoline group (p = 0.394). Prevalence of local pain in the overall study population was 60%. No significant statistical difference was achieved between groups 5 minutes or 24 hours after IVI in either pain scale evaluation. CONCLUSION: Administration of topical oxymetazoline 30 minutes before IVI is a single, harmless, cost-effective intervention that decreases the incidence of subconjunctival hemorrhage. This may considerably improve patient treatment satisfaction and promote compliance to IVI therapy.


Subject(s)
Conjunctiva/blood supply , Conjunctival Diseases/epidemiology , Diabetic Retinopathy/drug therapy , Eye Hemorrhage/prevention & control , Oxymetazoline/administration & dosage , Adrenergic alpha-Agonists/administration & dosage , Aged , Conjunctival Diseases/diagnosis , Conjunctival Diseases/prevention & control , Diabetic Retinopathy/diagnosis , Double-Blind Method , Eye Hemorrhage/diagnosis , Eye Hemorrhage/epidemiology , Female , Follow-Up Studies , Humans , Incidence , Intravitreal Injections , Male , Middle Aged , Prospective Studies , Treatment Outcome
15.
J Endod ; 45(3): 257-262, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30803532

ABSTRACT

INTRODUCTION: Needle-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. METHODS: Fifty 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. RESULTS: Anesthetic 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. CONCLUSIONS: The 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.


Subject(s)
Anesthesia, Dental/methods , Maxilla , Nasal Sprays , Oxymetazoline/administration & dosage , Tetracaine/administration & dosage , Administration, Intranasal , Adolescent , Adult , Cross-Over Studies , Drug Combinations , Female , Follow-Up Studies , Humans , Male , Single-Blind Method , Surveys and Questionnaires , Young Adult
16.
Laryngoscope ; 129(12): 2775-2781, 2019 12.
Article in English | MEDLINE | ID: mdl-30786035

ABSTRACT

OBJECTIVES/HYPOTHESIS: Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical hemostatic agent in the operating room during ear, nose, and throat surgery. There are limited data on oxymetazoline pharmacokinetics in children who undergo general anesthesia. We assessed the hemodynamic effects and systemic absorption of topically applied oxymetazoline in children undergoing various nasal procedures. STUDY DESIGN: Prospective trial. METHODS: Children ages 2 to 17 years undergoing functional endoscopic sinus surgery, turbinate resection, or adenoidectomy were enrolled. The surgeon placed oxymetazoline-soaked pledgets (1.5 mL of 0.05% solution) according to our usual clinical practice. Blood samples for oxymetazoline assay were drawn at 5, 10, 20, 45, 90, and 150 minutes, and hemodynamic data were recorded at 5-minute intervals. Data analysis included mixed-effects regression and population pharmacokinetic/pharmacodynamic modeling. RESULTS: The analysis included 27 patients, age 7 ± 4 years, who received between 2 and 12 pledgets (3-18 mL) of oxymetazoline. Relative bioavailability compared to the spray formulation was 2.3 (95% confidence interval [CI]: 1.6-3.2), with slow absorption from the mucosal surface (absorption half-life 64 minutes; 95% CI: 44-90). Mean arterial pressure did not increase with oxymetazoline instillation at the observed oxymetazoline serum concentrations (0.04-7.6 µg/L). CONCLUSIONS: Despite concerns regarding oxymetazoline administration to mucosal membranes, we found that hemodynamic changes were clinically negligible with our usual clinical use of pledgets soaked in oxymetazoline. Compared to data on oxymetazoline in spray formulation, bioavailability was increased twofold with pledgets, but systemic absorption was very slow, contributing to low serum concentrations and limited hemodynamic effects. LEVEL OF EVIDENCE: 1b. Laryngoscope, 129:2775-2781, 2019.


Subject(s)
Hemodynamics/physiology , Nasal Surgical Procedures/methods , Nose Diseases/surgery , Oxymetazoline/pharmacokinetics , Administration, Intranasal , Adolescent , Adrenergic alpha-Agonists/administration & dosage , Adrenergic alpha-Agonists/pharmacokinetics , Child , Child, Preschool , Female , Hemodynamics/drug effects , Humans , Intraoperative Period , Male , Nose Diseases/metabolism , Nose Diseases/physiopathology , Oxymetazoline/administration & dosage , Prospective Studies , Treatment Outcome
17.
Br J Dermatol ; 180(5): 1050-1057, 2019 05.
Article in English | MEDLINE | ID: mdl-30500065

ABSTRACT

BACKGROUND: Once-daily topical oxymetazoline cream 1·0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments. OBJECTIVES: To evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed. METHODS: In two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record ≥ 1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12 h postdose. RESULTS: Among 835 patients (oxymetazoline n = 415, vehicle n = 420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved ≥ 1-grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post-treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved ≥ 1-grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P<0.001). In the phase IV study, up to 80·2% of patients treated with oxymetazoline achieved at least moderate erythema improvement vs. up to 22·9% of patients treated with vehicle. The association between patients' satisfaction with facial skin redness and percentage of erythema improvement was statistically significant. CONCLUSIONS: Assessment of study photographs, with comparison to baseline, confirmed significant erythema reduction with oxymetazoline on the first day of application. Compared with the phase III trial results, significantly fewer vehicle recipients attained ≥ 1-grade CEA improvement, suggesting a mitigated vehicle effect. This methodology may improve the accuracy of clinical trials evaluating erythema severity.


Subject(s)
Erythema/diagnosis , Oxymetazoline/administration & dosage , Photography/standards , Rosacea/diagnosis , Severity of Illness Index , Erythema/drug therapy , Face , Female , Humans , Male , Middle Aged , Patient Reported Outcome Measures , Patient Satisfaction , Research Design/standards , Rosacea/drug therapy , Skin/diagnostic imaging , Skin/drug effects , Skin Cream/administration & dosage , Treatment Outcome
18.
Br J Dermatol ; 181(1): 65-79, 2019 07.
Article in English | MEDLINE | ID: mdl-30585305

ABSTRACT

BACKGROUND: Rosacea is a common chronic facial dermatosis. Classification of rosacea has evolved from subtyping to phenotyping. OBJECTIVES: To update our systematic review on interventions for rosacea. METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index and ongoing trials registers (March 2018) for randomized controlled trials. Study selection, data extraction, risk-of-bias assessment and analyses were carried out independently by two authors. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) was used to assess certainty of evidence. RESULTS: We included 152 studies (46 were new), comprising 20 944 participants. Topical interventions included brimonidine, oxymetazoline, metronidazole, azelaic acid, ivermectin and other topical treatments. Systemic interventions included oral antibiotics, combinations with topical treatments or other systemic treatments. Several studies evaluated laser or light-based treatment. We present the most current evidence for rosacea management based on a phenotype-led approach. CONCLUSIONS: For reducing temporarily persistent erythema there was high-certainty evidence for topical brimonidine and moderate certainty for topical oxymetazoline; for erythema and mainly telangiectasia there was low-to-moderate-certainty evidence for laser and intense pulsed light therapy. For reducing papules/pustules there was high-certainty evidence for topical azelaic acid and topical ivermectin; moderate-to-high-certainty evidence for doxycycline 40 mg modified release (MR) and isotretinoin; and moderate-certainty evidence for topical metronidazole, and topical minocycline and oral minocycline being equally effective as doxycycline 40 mg MR. There was low-certainty evidence for tetracycline and low-dose minocycline. For ocular rosacea, there was moderate-certainty evidence that oral omega-3 fatty acids were effective and low-certainty evidence for ciclosporin ophthalmic emulsion and doxycycline.


Subject(s)
Dermatology/methods , Evidence-Based Medicine/methods , Facial Dermatoses/therapy , Rosacea/therapy , Administration, Cutaneous , Administration, Oral , Anti-Bacterial Agents/administration & dosage , Brimonidine Tartrate/administration & dosage , Combined Modality Therapy/methods , Dermatologic Agents/administration & dosage , Drug Therapy, Combination/methods , Facial Dermatoses/classification , Facial Dermatoses/diagnosis , Humans , Intense Pulsed Light Therapy/methods , Low-Level Light Therapy/methods , Oxymetazoline/administration & dosage , Randomized Controlled Trials as Topic , Rosacea/classification , Rosacea/diagnosis , Severity of Illness Index , Treatment Outcome
19.
J Emerg Med ; 55(4): 455-464, 2018 10.
Article in English | MEDLINE | ID: mdl-30195946

ABSTRACT

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. OBJECTIVE: Our aim was to determine the effects of intranasal vasoconstrictors 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 antidysrhythmic medications, or had nasal abnormalities, such as epistaxis. Subjects were randomized to one of four 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 min for 30 min. 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 were also not significantly different from the saline group. CONCLUSIONS: 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.


Subject(s)
Administration, Intranasal , Blood Pressure/drug effects , Epistaxis/drug therapy , Vasoconstrictor Agents/administration & dosage , Anesthetics, Local/administration & dosage , Anesthetics, Local/pharmacology , Anesthetics, Local/therapeutic use , Blood Pressure/physiology , Double-Blind Method , Emergency Service, Hospital/organization & administration , Epinephrine/administration & dosage , Epinephrine/pharmacology , Epinephrine/therapeutic use , Epistaxis/etiology , Female , Humans , Hypertension/complications , Hypertension/drug therapy , Lidocaine/administration & dosage , Lidocaine/pharmacology , Lidocaine/therapeutic use , Male , Nasal Decongestants/administration & dosage , Nasal Decongestants/pharmacology , Nasal Decongestants/therapeutic use , Oxymetazoline/administration & dosage , Oxymetazoline/pharmacology , Oxymetazoline/therapeutic use , Phenylephrine/administration & dosage , Phenylephrine/pharmacology , Phenylephrine/therapeutic use , Placebos , Sodium Chloride/administration & dosage , Sodium Chloride/pharmacology , Sodium Chloride/therapeutic use , Vasoconstrictor Agents/therapeutic use
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