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Journal of Plastic, Reconstructive &... May 2023This study assesses the effects of topical oxymetazoline 0.1% on eyelid position, eye redness, and patient-perceived eye appearance in patients without severe ptosis. (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
This study assesses the effects of topical oxymetazoline 0.1% on eyelid position, eye redness, and patient-perceived eye appearance in patients without severe ptosis.
METHODS
This is a randomized double-blinded controlled trial conducted at a single institute. Patients aged 18-100 years were randomized to receive one drop of oxymetazoline hydrochloride 0.1% or placebo bilaterally. Marginal reflex distance (MRD) 1 and 2, palpebral fissure height, eye redness, and patient-perceived eye appearance were assessed at baseline and two hours after drop instillation. Primary outcome measures included the change in MRD1, MRD2, and palpebral fissure height. Secondary outcome measures included changes in eye redness and patient-perceived eye appearance after drop instillation.
RESULTS
In total, 114 patients were included, 57 treatment patients (mean age 36.4 ± 12.7 years, 31.6% male) and 57 controls (mean age 31.3 ± 10.1 years, 33.3% male). Baseline mean MRD1, MRD2, and palpebral fissure were similar between groups (p = 0.24, 0.45, and 0.23, respectively). Changes in MRD1 and eye redness in the treatment group were significantly greater than those in the control group (0.9 ± 0.9 mm vs. - 0.3 ± 0.4 mm, p < 0.001; - 2.6 ± 4.4 vs. - 0.5 ± 2.3, p = 0.002, respectively). Patient-perceived eye appearance was significantly improved in the treatment group compared to the controls (p = 0.002), with more treatment group patients also reporting increased eye size and decreased eye redness (p = 0.008, p = 0.003, respectively). There were 9 treatment-emergent adverse events (TEAEs) in 7 treatment group patients and 5 TEAEs in 5 control patients (p = 0.25), all of which were mild in severity.
CONCLUSIONS
Topical oxymetazoline 0.1% increases MRD1 and palpebral fissure height, decreases eye redness, and improves patient-perceived eye appearance.
Topics: Humans; Male; Young Adult; Adult; Middle Aged; Female; Oxymetazoline; Eyelids; Blepharoptosis; Patient Reported Outcome Measures
PubMed: 36996503
DOI: 10.1016/j.bjps.2023.02.006 -
Pediatrics Nov 2021The 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...
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.
Topics: Age Factors; Child; Child, Preschool; Female; Heart Rate; Humans; Hypertension; Intraoperative Complications; Male; Nasal Decongestants; Off-Label Use; Operating Rooms; Oxymetazoline; Perioperative Care
PubMed: 34607935
DOI: 10.1542/peds.2021-054271 -
Aesthetic Surgery Journal Aug 2023
Topics: Humans; Blepharoptosis; Oxymetazoline; Clostridium botulinum; Botulinum Toxins, Type A; Neuromuscular Agents
PubMed: 36978211
DOI: 10.1093/asj/sjad076 -
Clinical and Experimental Dermatology Apr 2022Erythromelalgia is an infrequent syndrome with a profound impact on quality of life. Its management is usually challenging and multiple treatments have been reported...
Erythromelalgia is an infrequent syndrome with a profound impact on quality of life. Its management is usually challenging and multiple treatments have been reported with variable response rates. To the best of our knowledge, we present the first case of erythromelalgia successfully treated with topical oxymetazoline.
Topics: Erythromelalgia; Humans; Oxymetazoline; Quality of Life
PubMed: 34905256
DOI: 10.1111/ced.15060 -
Fundamental & Clinical Pharmacology Apr 2023This study observed the cutaneous analgesic effect of adrenergic agonists when combined with lidocaine. We aimed at the usefulness of four adrenergic agonists and...
This study observed the cutaneous analgesic effect of adrenergic agonists when combined with lidocaine. We aimed at the usefulness of four adrenergic agonists and epinephrine as analgesics or as tools to prolong the effect of local anesthetics using a model of cutaneous trunci muscle reflex (pinprick pain) in rats. We showed that subcutaneous four adrenergic agonists and epinephrine, as well as the local anesthetic bupivacaine and lidocaine, developed a concentration-dependent cutaneous analgesia. The rank order of the efficacy of different compounds (ED ; median effective dose) was epinephrine [0.013 (0.012-0.014) μmol] > oxymetazoline [0.25 (0.22-0.28) μmol] > naphazoline [0.42 (0.34-0.53) μmol] = bupivacaine [0.43 (0.37-0.50) μmol] > xylometazoline [1.34 (1.25-1.45) μmol] > lidocaine [5.86 (5.11-6.72) μmol] > tetrahydrozoline [6.76 (6.21-7.36) μmol]. The duration of full recovery caused by tetrahydrozoline, oxymetazoline, or xylometazoline was greater (P < 0.01) than that induced via epinephrine, bupivacaine, lidocaine, or naphazoline at equianesthetic doses (ED , ED , and ED ). Co-administration of lidocaine (ED ) with four adrenergic agonists or epinephrine enhanced the cutaneous analgesic effect. We observed that four adrenergic agonists and epinephrine induce analgesia by themselves, and such an effect has a longer duration than local anesthetics. Co-administration of lidocaine with the adrenergic agonist enhances the analgesic effect, and the cutaneous analgesic effect of lidocaine plus naphazoline (or oxymetazoline) is greater than that of lidocaine plus epinephrine.
Topics: Rats; Animals; Lidocaine; Anesthetics, Local; Naphazoline; Oxymetazoline; Rats, Sprague-Dawley; Pain; Analgesia; Bupivacaine; Analgesics; Epinephrine; Adrenergic Agonists
PubMed: 36394965
DOI: 10.1111/fcp.12853 -
Otolaryngology--head and Neck Surgery :... Jan 2012To investigate possible ototoxic effects of a one-time application of oxymetazoline drops in a chinchilla animal model with tympanostomy tubes. Study Design. A... (Comparative Study)
Comparative Study
OBJECTIVE
To investigate possible ototoxic effects of a one-time application of oxymetazoline drops in a chinchilla animal model with tympanostomy tubes. Study Design. A prospective, controlled animal study.
SETTING
The Research Institute of the Montreal's Children Hospital, McGill University Health Centre.
SUBJECTS AND METHODS
Ventilation tubes were inserted in both ears of 12 animals. One ear was randomly assigned to receive oxymetazoline drops (0.5 mL). The contralateral ear did not receive any drops, serving as a control ear.
OUTCOME MEASURES
Distortion product otoacoustic emissions were measured bilaterally for a wide range of frequencies (between 1 and 16 kHz) before and 1 day after the application of oxymetazoline in the experimental ears. Two months later, the animals were sacrificed and all cochleae were dissected out and processed for scanning electron microscopy.
RESULTS
In this established chinchilla animal model, the measured distortion product otoacoustic emission amplitudes and the morphological appearance on scanning electron microscopy were similar for both control and experimental ears.
CONCLUSION
Oxymetazoline did not cause ototoxicity in a chinchilla animal model 2 months after a single application via a tympanostomy tube.
Topics: Administration, Topical; Animals; Cerebrospinal Fluid Otorrhea; Chinchilla; Disease Models, Animal; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Microscopy, Electron, Scanning; Middle Ear Ventilation; Nasal Decongestants; Otoacoustic Emissions, Spontaneous; Oxymetazoline; Postoperative Complications; Prospective Studies; Rabbits; Scala Vestibuli
PubMed: 21846927
DOI: 10.1177/0194599811419082 -
Pharmacology Oct 1996Oxymetazoline, an alpha 2 agonist, was active in lowering intraocular pressure in normal and sympathetically denervated rabbit eyes. Ocular hypotension was accompanied...
Oxymetazoline, an alpha 2 agonist, was active in lowering intraocular pressure in normal and sympathetically denervated rabbit eyes. Ocular hypotension was accompanied by decreased aqueous humor inflow. Topical pretreatment with rauwolscine, an alpha 2 antagonist, reduced the oxymetazoline-induced hypotensive effect more in contralateral than in ipsilateral eyes indicating the possible involvement of central alpha 2 adrenoceptors. Efaroxan, a relatively selective imidazoline antagonist, and diclofenac, a cyclooxygenase inhibitor, failed to inhibit the oxymetazoline-induced ocular hypotensive response. Oxymetazoline induced mydriasis in treated eyes at all doses. In in vitro studies, oxymetazoline inhibited isoproterenol-stimulated cAMP production in rabbit iris-ciliary bodies and cultured rabbit nonpigmented ciliary epithelial cells. The inhibition of cAMP accumulation induced by oxymetazoline was antagonized by rauwolscine or by BRL-44408, a relatively selective alpha 2A-adrenoceptor antagonist. These data indicate that oxymetazoline lowered intraocular pressure by activating alpha 2A receptors (ciliary epithelium) and that the ocular hypotensive effect was not totally dependent on intact sympathetic nerves. Results suggest that mechanisms involving centrally mediated effects of oxymetazoline are probable and this possibility is currently under investigation.
Topics: Adrenergic alpha-Agonists; Animals; Aqueous Humor; Ciliary Body; Cyclic AMP; Denervation; Epithelium; Female; Intraocular Pressure; Iris; Lighting; Male; Oxymetazoline; Pupil; Rabbits
PubMed: 8958565
DOI: 10.1159/000139438 -
The Annals of Otology, Rhinology, and... Aug 2005This study was performed to explore the antimicrobial activity of two commercially available oxymetazoline hydrochloride preparations against the common pathogens of...
OBJECTIVES
This study was performed to explore the antimicrobial activity of two commercially available oxymetazoline hydrochloride preparations against the common pathogens of otitis media and to demonstrate the lack of ototoxicity of these agents and of United States Pharmacopeia (USP) oxymetazoline in a standard animal model.
METHODS
Disc diffusion assays and minimum inhibitory concentration studies against American Type Culture Collection reference strains of common middle ear pathogens were used to evaluate the antimicrobial activity of oxymetazoline solutions and fluoroquinolone drops, and outer hair cell counts were performed on scanning electron micrographs of guinea pig basal cochlear segments after chronic exposure to oxymetazoline solutions and positive and negative controls.
RESULTS
Oxymetazoline nasal spray and eyedrops had activity against all species tested except Haemophilus influenzae and Pseudomonas aeruginosa. The USP oxymetazoline had limited antimicrobial activity. Oxymetazoline nasal spray, oxymetazoline eyedrops, and USP oxymetazoline had ototoxicity profiles indistinguishable from that of the saline solution control.
CONCLUSIONS
Commercially available oxymetazoline solutions are active against several of the common pathogens of otitis media. This antimicrobial activity is not due to oxymetazoline, and is more likely due to preservatives present in the solutions. The solutions tested are not ototoxic to guinea pig outer hair cells. Oxymetazoline solutions are potential substitutes for broad-spectrum antibiotic drops after tympanostomy tube placement.
Topics: Adrenergic alpha-Agonists; Aerosols; Animals; Bacteria; Cell Count; Cochlea; Ear, Middle; Guinea Pigs; Hair Cells, Auditory, Outer; Microbial Sensitivity Tests; Microscopy, Electron, Scanning; Ophthalmic Solutions; Oxymetazoline; Preservatives, Pharmaceutical; Solutions
PubMed: 16190099
DOI: 10.1177/000348940511400811 -
The Laryngoscope Dec 2019Oxymetazoline 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... (Clinical Trial)
Clinical Trial
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.
Topics: Administration, Intranasal; Adolescent; Adrenergic alpha-Agonists; Child; Child, Preschool; Female; Hemodynamics; Humans; Intraoperative Period; Male; Nasal Surgical Procedures; Nose Diseases; Oxymetazoline; Prospective Studies; Treatment Outcome
PubMed: 30786035
DOI: 10.1002/lary.27760 -
American Journal of Rhinology & Allergy May 2016Although nasal steroids are the mainstay treatments in nasal polyposis, up to one-half of patients do not respond and need surgical treatment. This study aimed to... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Although nasal steroids are the mainstay treatments in nasal polyposis, up to one-half of patients do not respond and need surgical treatment. This study aimed to evaluate whether oxymetazoline administration produces any additive effect on nasal steroid therapy and whether rebound congestion develops after oxymetazoline treatment.
METHODS
Sixty-eight patients with nasal polyposis were randomly assigned in a 1:1 ratio to receive either oxymetazoline plus mometasone furoate nasal spray (MFNS) or placebo plus MFNS, 2 sprays per nostril twice daily, with an interval of 5 minutes between each medication for 4 weeks. All the patients were then treated with MFNS, 2 sprays per nostril twice daily for 2 weeks. The nasal symptoms score, peak inspiratory flow index, nasal mucociliary clearance time (NMCCT), and total nasal polyps score were used to evaluate treatment outcomes. An intention-to-treat analysis was performed, and a worst case sensitivity analysis was applied to missing cases.
RESULTS
Thirty-four patients were allocated to the oxymetazoline-MFNS group, and 34 to the placebo-MFNS group. One patient in each group was lost to last-visit follow-up. At 4 weeks after beginning treatment, the oxymetazoline-MFNS group showed significantly greater improvement in blocked nose, hyposmia, peak flow, NMCCT, and total nasal polyps score than the placebo-MFNS group. During the nasal steroid phase, both groups showed continuing improvement in all outcome variables. However, the oxymetazoline-MFNS group still showed significantly greater improvement in blocked nose, hyposmia, NMCCT, and total nasal polyps score, but not peak flow, than the placebo-MFNS group at the end of the study.
CONCLUSION
The use of nasal steroids with oxymetazoline was more effective over 6 weeks than nasal steroids alone in improving blocked nose, hyposmia, nasal mucociliary clearance, and polyp size in treatment of nasal polyposis. There was no evidence of rebound congestion after 4 weeks of oxymetazoline treatment.
Topics: Administration, Intranasal; Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Inflammatory Agents; Drug Synergism; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Oxymetazoline; Treatment Outcome; Young Adult
PubMed: 27216350
DOI: 10.2500/ajra.2016.30.4294