Avaliação do colírio de brimonidina 0, 2% em comparação à nafazolina 0,025% + feniramina 0,3% nas cirurgias de estrabismo / Evaluation of 0.2% brimonidine eye drops compared to 0.025% naphazoline + 0.3% pheniramine in strabismus surgery

RESUMO Objetivo: Avaliar o efeito do colírio de brimonidina 0,2% na redução da hiperemia e do sangramento ocular durante as cirurgias de estrabismo, em comparação com o colírio de nafazolina 0,025% + feniramina 0,3%. Métodos: Foram avaliados 14 pacientes com estrabismo e indicação de correção cirúrgica bilateral. Foi instilado antes do procedimento, de forma aleatória, um colírio em cada olho dos pacientes avaliados. A análise subjetiva da hiperemia conjuntival e do sangramento perioperatório foi realizada de forma duplo-cega, por dois cirurgiões. A avaliação objetiva do nível de hiperemia conjuntival foi realizada por análise das imagens obtidas por meio do software ImageJ®. Resultados: A análise de modelos multivariados de efeito misto indicou diferenças estatisticamente significantes entre os grupos em relação à hiperemia (avaliador 2) e ao sangramento intraoperatório (avaliadores 1 e 2), com maiores escores nos casos tratados com colírio de nafazolina + feniramina. Entretanto, não houve diferença estatística na análise objetiva realizada por meio da saturação de cores obtidas pelo programa ImageJ®. Conclusão: O colírio de brimonidina pode ser superior ao colírio de nafazolina + feniramina na redução do sangramento, levando-se em conta apenas a análise subjetiva.

ABSTRACT Objective: To evaluate the effect of 0.2% brimonidine eye drops in reducing hyperemia and ocular bleeding during strabismus surgeries, in comparison with 0.025% naphazoline + 0.3% pheniramine eye drops. Methods: Fourteen patients with strabismus and indication for bilateral surgical correction were evaluated. Before the procedure, the eye drops were instilled randomly in each eye of the evaluated patients. The subjective analysis of conjunctival hyperemia and perioperative bleeding was performed in a double-blind manner, by 02 surgeons. The objective assessment of the level of conjunctival hyperemia was performed by analyzing the images obtained using the ImageJ® software. Results: The analysis of multivariate mixed effect models indicated statistically significant differences between the groups in relation to hyperemia (rater 2) and intraoperative bleeding (raters 1 and 2) with higher scores in cases treated with naphazoline + pheniramine eye drops. However, there were no statistically significant differences in the objective analysis of color saturation obtained by the ImageJ® program. Conclusion: Brimonidine eye drops may be superior to naphazoline + pheniramine eye drops in reducing bleeding, taking into account the subjective analysis only.

Exposure to antazoline-naphazoline eye drops during pregnancy and the risk of congenital malformations: a Danish nationwide cohort study.

PURPOSE: To investigate whether exposure to antazoline-naphazoline eye drops in the first trimester of pregnancy was associated with an increased risk of malformations in humans. METHODS: All women giving live birth between 1997 and 2011 in Denmark were included in this nationwide cohort study. All women redeeming at least one prescription of antazoline-naphazoline eye drops during the first 84 days of pregnancy were identified. Logistic regression was used to estimate the odds ratios of malformations among exposed offspring compared to non-exposed offspring. RESULTS: We identified 977 706 births between 1997 and 2011. A total of 3061 women (0.32%) were exposed to antazoline-naphazoline eye drops in the first trimester of pregnancy. The rate of congenital malformations was 3.0% (n = 93) in exposed offspring and 3.5% (n = 33 594) in unexposed offspring. First-trimester exposure to antazoline-naphazoline was not associated with major congenital malformations overall (odds ratio: 0.88, 95% confidence interval: 0.71-1.09) or with any specific major malformation. The number of redeemed prescriptions was unchanged during all trimesters of pregnancy as compared to before and after pregnancy (p < 0.05). CONCLUSION: Exposure to antazoline-naphazoline eye drops in the first trimester of pregnancy appears not to be associated with increased teratogenic risk.

Intoxicación grave con nafazolina: puesta al día a partir de un error terapéutico / Severe poisoning with naphazoline: update from a therapeutic error

La nafazolina es un fármaco utilizado como descongestivo, generalmente, en pacientes adultos. Su indicación en pediatría no es frecuente; su uso está aprobado a partir de los 12 años por los efectos tóxicos que posee. La intoxicación en niños genera un cuadro clínico potencialmente grave. Se caracteriza por la aparición inmediata de hipotonía, deterioro del sensorio, hipotermia y bradicardia con grado variable de compromiso clínico. Si bien es una intoxicación infrecuente, la anamnesis y el manejo inicial del paciente son la clave en su evolución. Se presenta a un niño de 4 años que, por un error terapéutico, recibió este fármaco y se destaca la instauración rápida y potencialmente grave del cuadro clínico.

Naphazoline is a drug commonly used as a decongestant in adult patients. Its indication in Pediatrics is not frequent, being approved its use from the age of 12 for the toxic effects it possesses. Intoxication in children generates a potentially serious clinical picture. It is characterized by the immediate appearance of hypotonia, deterioration of the sensory, hypothermia and bradycardia of variable degree of clinical compromise. Although it is an infrequent intoxication, the anamnesis and the initial management of the patient are the key in the evolution. We present a 4-year-old boy who, as a therapeutic error, receives this drug, emphasizing the rapid and potentially severe establishment of the clinical picture.

[Severe poisoning with naphazoline: update from a therapeutic error]. / Intoxicación grave con nafazolina: puesta al día a partir de un error terapéutico.

Naphazoline is a drug commonly used as a decongestant in adult patients. Its indication in Pediatrics is not frequent, being approved its use from the age of 12 for the toxic effects it possesses. Intoxication in children generates a potentially serious clinical picture. It is characterized by the immediate appearance of hypotonia, deterioration of the sensory, hypothermia and bradycardia of variable degree of clinical compromise. Although it is an infrequent intoxication, the anamnesis and the initial management of the patient are the key in the evolution. We present a 4-year-old boy who, as a therapeutic error, receives this drug, emphasizing the rapid and potentially severe establishment of the clinical picture.

La nafazolina es un fármaco utilizado como descongestivo, generalmente, en pacientes adultos. Su indicación en pediatría no es frecuente; su uso está aprobado a partir de los 12 años por los efectos tóxicos que posee. La intoxicación en niños genera un cuadro clínico potencialmente grave. Se caracteriza por la aparición inmediata de hipotonía, deterioro del sensorio, hipotermia y bradicardia con grado variable de compromiso clínico. Si bien es una intoxicación infrecuente, la anamnesis y el manejo inicial del paciente son la clave en su evolución. Se presenta a un niño de 4 años que, por un error terapéutico, recibió este fármaco y se destaca la instauración rápida y potencialmente grave del cuadro clínico.

[About the safety of application of nasal decongestants in the practice of pediatricians]. / O bezopasnosti primeneniia nazal'nykh dekongestantov v pediatricheskoi praktike.

Undesirable effects of the application of the intransal vasoconstricting medications are a frequent occurrence in the pediatric practice. The objective of the present study was to evaluate the role of the intranasal vasoconstricting medications in the structure of the means and methods currently available for the treatment of toxicological pathologies based at a multi-field clinical hospital. The retrospective analysis of the medical histories of the patients admitted to the toxicological department and annual reports for the period from 2015 to 2016 was undertaken. The study has demonstrated that intoxication associated with the use of the intranasal vasoconstricting medications was the most common cause of hospitalization of the children in the toxicological departments. Intoxication of this origin accounted for 15-20% of the total number of toxicological pathologies among the children. The cases of intoxication are most frequently documented in the group of children at the age between 1 and 3 years. The risk of the undesirable serious complications is especially high after the application of naphazoline-based intranasal vasoconstricting medications (71.7-77.4% of all the cases of intoxication with these products). It is concluded that the use of intranasal vasoconstricting medications in the pediatric practice should be carried out under the strict control, with the naphazoline-based preparations being totally excluded from the application.

Effect of Low-Concentration, Nonmydriatic Selective Alpha-Adrenergic Agonist Eyedrops on Upper Eyelid Position.

BACKGROUND: Ptosis after botulinum toxin injection is a disturbing complication. Decongestant and antiglaucoma eyedrops are frequently prescribed for temporary improvement of eyelid ptosis. Although frequently cited on informal communications, the effect of these drugs on eyelid position has never been compared in a formal study. OBJECTIVE: To measure the effect of low-concentration, nonmydriatic selective alpha agonist eyedrops on upper eyelid position. METHODS AND MATERIALS: This nonrandomized clinical trial enrolled 20 healthy subjects aged 18 to 50 years. The upper margin-reflex distance (MRD1) was measured before, 30, 60, and 120 minutes after administration of 1 drop of brimonidine 0.2%, phenylephrine 0.12%, or naphazoline 0.05% to the left eye. RESULTS: There was no statistically significant difference in mean MRD1 between the brimonidine and phenylephrine groups when comparing baseline to all other study time points. After administration of naphazoline 0.05%, MRD1 had a mean increase of 0.56 ± 0.11 mm (p < 0.001) after 30 minutes, 0.47 ± 0.12 mm (p = 0.001) after 60 minutes, and 0.26 ± 0.09 mm (p = 0.028) after 120 minutes when compared with baseline. CONCLUSION: Brimonidine 0.2% and phenylephrine 0.12% have no effect on eyelid aperture, but naphazoline 0.05% eyedrops could be useful for temporary relief of upper eyelid ptosis in selected patients.

[. Oсumethyl in the treatment of allergic diseases of eyelids and conjunctiva]. / Okumetil v kompleksnom lechenii allergicheskikh zabolevanii vek i kon''yunktivy.

Treatment of allergic diseases of eyelids and conjunctiva (conjunctivites and blepharoconjunctivites) often presents difficulties due to peculiarities of their pathogenesis - allergic and vascular reactions, disorder of lacrimal production, meibomian gland dysfunction, and possible bacterial contamination. It has been suggested to use Ocumethyl, which contains zinc sulfate (binding, drying, anti-inflammatory, and antiseptic effect), diphenhydamine hydrochloride (an Н1-antihistamine that decreases capillary permeability and helps resolve conjunctival and eyelid edema), naphazoline hydrochloride (a sympathomimetic notable for its strong, rapid, and long-lasting vasoconstrictive effect), and methylene blue (antiseptic effect, disintoxication, and antioxidant activity). A total of 80 patients with chronic allergic conjunctivitis, blepharoconjuntivitis, or giant papillary conjunctivitis associated with contact lens wearing were treated with Ocumethyl instillations (3 times daily for 15-30 days). A clinically significant effect was obtained in 77-91% of patients depending on the disease entity.

[Treatment of pure ocular myasthenia: a proposal from Japan MG registry 2012].

Autoimmune myasthenia gravis (MG), affecting both ocular and generalized muscles, results in various symptoms. Ocular myasthenia (OM) is a form of MG that is clinically restricted to extrinsic ocular muscles. Clinical signs of OM can be highly variable, ranging from mild unilateral ptosis to complete opthalmoplegia. There is no clear evidence supporting corticosteroid use for OM. We studied 123 patients whose symptoms were limited to ocular muscles with duration of illness ≥ 2 years. We classified them into two groups: 36 patients with ptosis alone (the ptosis group) and 87 with diplopia with or without ptosis (the diplopia group). Prednisolone (PSL) and immunosuppressants were less frequently used in the ptosis group. There were no significant differences in the post-treatment condition and quality-of-life (QOL) impairment between the two groups. Forty-seven (38%) patients who failed to gain minimal manifestation or better status with PSL ≤ 5 mg/day (the unfavorable condition) showed severe QOL impairment. Ocular-QMG score was a factor associated with the unfavorable condition. A treatment strategy, discriminated by ptosis or diplopia, is necessary to improve the ocular symptoms and QOL in OM patients with the unfavorable condition.

Ocular pain after intravitreal injection.

PURPOSE: To evaluate the efficacy of different anesthetics and topical anti-inflammatory treatment in patients undergoing intravitreal injections (IVI). METHODS: Prospective, randomized, double masked, comparative study. Patients undergoing 0.05 mL IVI were randomized to two different preoperative anesthetic regimes (regime A [0.5% tetracaine + naphazoline] versus regime B [5% lidocaine]) and two different post-injection topical protocols (protocol 1 [tobramycin qid] versus protocol 2 [tobramycin qid + diclofenac qid]). Patients were trained to score pain using a numerical rating pain scale from 0 (no pain) to 10 (excruciating pain) immediately after the injection, 30 min and 24 h later. Patients were instructed to take oral paracetamol (650-1000 mg, adjusted to the patient's weight) every six hours ad lib if necessary. RESULTS: A total of 156 patients were enrolled; 86 patients were randomized to regime A and 70 to regime B; 78 patients were assigned to each of the post-injection topical protocols. The average pain score immediately after the IVI was 2.77 (SD 2.12) for the whole group (2.85, SD 2.23 with tetracaine and 2.67, SD 2.00 with lidocaine; p = 0.73, Mann-Whitney U-test). Twenty-four hours later, the average pain score was 1.84, SD 2.45 (topical diclofenac + tobramycin) versus 1.75, SD 1.83 (topical tobramycin; p = 0.46, Mann-Whitney U-test). Forty-seven patients (30%) required oral paracetamol (average 3.3 and range 1-5 tablets). Conjunctival hemorrhage 30 min after the injection was less frequent and severe in eyes treated with topical naphazoline (p = 0.055, Mann-Whitney U-test). CONCLUSIONS: Topical tetracaine and lidocaine provide similar anesthesia before IVI. Topical diclofenac does not seem to reduce pain scores after IVI.

Topical naphazoline in the treatment of myasthenic blepharoptosis.

INTRODUCTION: When treating ocular myasthenia gravis (MG), the risk/benefit profile of corticosteroids is unclear, and acetylcholinesterase inhibitors are not very effective. We examined the efficacy of topical naphazoline in the treatment of myasthenic blepharoptosis. METHODS: Sixty MG patients with blepharoptosis (32 with ocular symptoms only and 28 with mild generalized symptoms) were enrolled in a multicenter open trial of topical naphazoline. The effects were reported by patients via a questionnaire and were also confirmed for each patient at the clinic. RESULTS: Among 70 eyes of 60 patients, 20 eyes (28.6%) of 17 patients (28.3%) exhibited a marked response (full eye opening), and 24 eyes (34.3%) of 20 patients (33.3%) showed a good response (adequate but incomplete eye opening). Topical naphazoline was evaluated as useful in the treatment of myasthenic blepharoptosis by >70% of the patients. CONCLUSIONS: Topical naphazoline was found to be an effective supplementary symptomatic treatment for myasthenic blepharoptosis.

Treatment of allergic conjunctivitis: results of a 1-month, single-masked randomized study.

PURPOSE: To compare the effects of topical antiallergic eyedrops in relieving the signs and symptoms of patients with allergic conjunctival pathology. METHODS: In this multicenter, single-masked, randomized study, 240 patients with signs and symptoms of allergic conjunctivitis were randomized to receive 1 of the following 8 treatments twice daily: cromolyn sodium/chlorpheniramine maleate, diclofenac, epinastine, fluorometholone, ketotifen, levocabastine, naphazoline/antazoline, and olopatadine. Clinical signs and symptoms were evaluated by a masked operator using a 10-point scale at the moment of enrollment (day 0) and at weeks 1, 2, and 4. The percentage of patients achieving at least a small (at least 50% reduction of the total scale score) or a good (at least 75%) improvement of signs and symptoms was calculated at each visit. Tolerability was also evaluated as the duration of discomfort after instillation. RESULTS: All drugs gave some improvement in symptoms in more than 85% of cases. Epinastine and olopatadine obtained at least a good relief of symptoms in 37% and 33% of cases at week 1. At the end of the study, good improvement of symptoms was obtained in at least 70% of patients by epinastine, ketotifen, fluorometholone, and olopatadine, whereas a 75% improvement for signs was obtained only by fluorometholone and ketotifen. Naphazoline/antazoline induced higher discomfort compared to the other study treatments (p<0.0001). CONCLUSIONS: The efficacy of epinastine, ketotifen, and olopatadine in the treatment of allergic conjunctivitis was comparable to fluorometholone. Naphazoline/antazoline had lower tolerability than the other study treatments.

Intranasal lidocaine plus naphazoline nitrate improves surgical conditions and perioperative analgesia in septorhinoplasty surgery.

BACKGROUND: Septorhinoplasty is a traumatic procedure that is associated with epistaxis and postoperative pain. The primary objective of this randomized double-blind controlled trial was to determine whether intranasal 5% lidocaine plus naphazoline decreases postoperative pain and lessens the use of rescue analgesics. METHODS: After induction of general anesthesia and laryngeal topical anesthesia with 5% lidocaine, 28 adult patients, scheduled to undergo septorhinoplasty, were randomly assigned to one of two groups, either topical intranasal saline 20 ml (control group) or intranasal 5% lidocaine plus naphazoline solution 0.2 mg ml(-1) (lidocaine group). The perioperative dose of sufentanil, the mean end-tidal concentration of isoflurane, and surgeon satisfaction with the operative field were recorded. In the lidocaine group, plasma lidocaine concentrations were sampled 15, 20, 25, 35, 45, and 55 min after induction of anesthesia. Visual analogue scale pain scores were recorded 30, 60, 90, and 120 min after the patients arrived in the postanesthesia care unit and 24 h after surgery. Consumption of morphine rescue analgesia and the occurrence of any side effects were recorded at the end of the 24-h study period. RESULTS: The intranasal lidocaine-naphazoline application decreased isoflurane requirements [median values: 0.8% (0.7-1.5) vs. 1.2% (0.9-1.8), respectively; P = 0.04] and enhanced surgical conditions. Patients in the lidocaine group experienced less postoperative pain than the control group [1 h after surgery: median values of visual analogue scale: 0 (0-20) vs. 50 (30-80), respectively; P = 0.001], and they required fewer doses of subcutaneous morphine. Total plasma concentrations of lidocaine remained below 4 microg ml(-1) throughout the study period. CONCLUSIONS: Intranasal lidocaine plus naphazoline is a simple and efficient technique for decreasing intra- and postoperative pain and for lessening rescue analgesic requirements in the postoperative period after septorhinoplasty. Toxic plasma concentrations of lidocaine were not reached.

Influence of the ageing phenomenon on the low-frequency electrical impedance behavior of naphazoline hydrochloride solutions and paracetamol syrup.

The influence of the ageing process on the low frequency behavior of some electrical parameters of naphazoline hydrochloride solutions at 0.5% and 1% in concentration and of 2% paracetamol syrup, is studied. The impedance measurements were performed, in the range between 200 Hz and 1 MHz, using an impedance analyzer and a cell for liquids with plane parallel electrodes whose separation can be changed by using a set of spacers, provided by the manufacturer, in order to get better control of the influence of electrodes polarization effect. The ageing state was artificially generated by dilution and/or heating separated procedures. The results show that this dielectric technique can be used as a good quality complementary control technique.