Cyclopentolate eye drops-induced anaphylaxis in an infant.

BACKGROUND: Cyclopentolate is frequently used as a mydriatic agent during ophthalmological examinations in childhood and hypersensitivity reactions associated with this drug are rare. We aim to report an infant who experienced anaphylaxis due to cyclopentolate eye drops. CASE: A nine-month-old girl, who was being followed up with a diagnosis of retinoblastoma, presented for consultation for urticaria, cough, stridor, and dyspnea that developed after the administration of topical cyclopentolate to the eyes. The patient was diagnosed with anaphylaxis and treated with adrenaline. During the follow-up, tropicamide was used safely as an alternative drug. CONCLUSIONS: In children, hypersensitivity reactions due to cyclopentolate are very rare. Only four pediatric patients were reported in the literature to have developed an allergic reaction after the administration of cyclopentolate eye drops. We present here the youngest patient who developed anaphylaxis with cyclopentolate eye drops. Anaphylaxis due to cyclopentolate should be kept in mind, rapidly recognized, and treated when a reaction develops.

A Survey of Neonatal Nurses on Mydriatic Regimens Used in Neonatal Retinopathy of Prematurity Eye Examinations.

OBJECTIVE: This study was aimed to determine mydriatic regimen(s) used in neonatal units in Aotearoa, New Zealand (NZ), and Australia and to estimate the frequency of adverse drug events following mydriatic administration in preterm neonates. STUDY DESIGN: A cross-sectional survey was sent to neonatal nursing staff listed in the Australian and New Zealand Neonatal Network contact list. Participants were asked to state what mydriatic regimen they use, and to estimate the frequency of adverse drug events when eye drops were administered for retinopathy of prematurity eye examinations (ROPEE). RESULTS: Thirteen different mydriatic regimens were identified; phenylephrine 2.5% and cyclopentolate 0.5% (1 standard drop of each) was the most commonly used regimen. Two of the regimens exceeded adult doses and five regimens included a mydriatic that is equivalent to an adult dose. Following mydriatic instillation, the three most common adverse effects were apnea, tachycardia, and periorbital pallor. CONCLUSION: Low-concentration single-microdrop regimens are currently in use and resulting in successful ROPEE, yet doses exceeding adult doses are in use throughout Aotearoa, NZ, and Australian units. We know from this dataset that neonates are experiencing unwanted and potentially preventable, adverse effects associated with mydriatics, and every effort should be made to minimize this risk. KEY POINTS: · Thirteen different regimens are in use in Aotearoa, NZ, and Australia.. · Three regimens use doses in excess of adult doses.. · Phenylephrine 2.5% and cyclopentolate 0.5% (one standard drop of each) is the most common regimen.

Delirium caused by topical administration of cyclopentolate for cataract surgery in mild cognitive impairment due to Alzheimer's disease: A case report.

RATIONALES: Cholinergic modification by anticholinergic medication can produce adverse effects in central nervous system (CNS) and cyclopentolate is an antimuscarinic agent widely used for ophthalmologic management. We demonstrate a rare case of hyperactive delirium caused by topical administration of cyclopentolate in a patient with amnestic mild cognitive impairment (MCI) due to Alzheimer's disease (AD). PATIENT CONCERNS: A 74-year-old man showed acute confusion after preparation for cataract operation in day surgery clinic. The patient became confused and agitated after instillation of topical cyclopentolate drop into the eye and the symptoms persisted over several hours. DIAGNOSIS: Previously the patient had been diagnosed with amnestic MCI with the finding of bilateral medial temporal atrophy on brain magnetic resonance imaging. 18F-flutemetamol positron emission tomography scan demonstrated multifocal amyloid deposition in the brain. INTERVENTIONS: The patient was closely observed with the supportive management. OUTCOMES: The patient began to recover 5 h after the onset of symptoms and the cognitive function was reverted to previous state within 24 h. LESSONS: It is well known that several drugs with anticholinergic effects used in perioperative periods make the patients susceptible to delirium, but even the topical administration of cyclopentolate for cataract surgery also produce adverse CNS effects in a vulnerable patient who is diagnosed with MCI due to AD in this case.

Randomised controlled pilot trial comparing low dose and very low- dose microdrop administration of phenylephrine and cyclopentolate for retinopathy of prematurity eye examinations in neonates.

AIMS: To determine ifVery low dose mydriatic eye microdrop regimen sufficiently dilates the pupil (above 4.1 mm) compared with the currently used low dose mydriatic eye microdrop regimen.Cardiovascular, gastrointestinal and respiratory adverse effects occur following eye drop instillation. METHODS: Seventeen premature infants were recruited into this prospective, randomised controlled pilot trial in January 2017 to November 2018. Data were collected from the single-centre Neonatal Intensive Care Unit, Dunedin Hospital, New Zealand. The inclusion criteria were birth weight less than 1500 g or gestational age less than 31 weeks, or any premature infant requiring red reflex testing. Infants were randomised to receive either phenylephrine 1% or 0.5% and cyclopentolate 0.2% or 0.1%, 1 microdrop in both eyes. Efficacy outcome measures were pupil size at retinopathy of prematurity eye examination (ROPEE) and ophthalmologist rating of ease of screen. RESULTS: All participants had sufficient pupillary dilation for a successful ROPEE. Ophthalmologists rated the ROPEE as easy for 90% of all examinations. Pupil dilation measurements at the time of examination, mean±SD, 4.8±0.2 (95% CI 4.5 to 5.2) mm for treatment A and 5±0.2 (95%CI 4.6 to 5.4) mm for treatment B (p=0.61). There were no statistically significant differences between the groups for safety data. CONCLUSIONS: Very low dose microdrop administration of phenylephrine and cyclopentolate appears to be effective at sufficiently dilating the neonatal pupil for ROPEEs. Low dose and very low dose microdrop mydriatic regimens may also reduce the risk of unwanted adverse effects associated with these medicines. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (reference ACTRN12616001266459p).

Adverse reactions to 1% cyclopentolate eye drops in children: an analysis using logistic regression models.

PURPOSE: To determine the frequency, symptoms and risk factors for adverse reactions to two-times instillation of 1% cyclopentolate in children. STUDY DESIGN: Prospective, observational study. METHODS: The subjects were 646 patients who underwent cycloplegic refraction with cyclopentolate (mean age; 7.0 ± 3.5 years, age range; 0-15 years). Five minutes after instillation of 0.4% oxybuprocaine hydrochloride, a 1% cyclopentolate eye drop was instilled twice, with an interval of 10 min. Fifty minutes later, two certified orthoptists evaluated adverse reactions using a questionnaire and interviewed the patients' guardians. The relationship between the adverse reaction rates and age, gender, additional instillation, complications of the central nervous system (CNS), time of day and season were analysed using binominal and polytomous logistic regression models. RESULTS: The overall frequency of adverse reactions was 18.3% (118/646 patients). The main symptoms included conjunctival injection (10.5%, 68/646), drowsiness (6.8%, 44/646) and facial flush (2.2%, 14/646). The odds ratio (OR) of conjunctival injection increased with patient's age (p < 0.05), in boys (p < 0.01) and in winter (p < 0.001). In contrast, the OR of drowsiness decreased with age (p < 0.001). Facial flush was observed mostly in children younger than 4 years. CNS complications were not a significant risk factor for any of the symptoms. CONCLUSIONS: Adverse reactions to 1% cyclopentolate eye drops were more frequent than previously expected, but all were mild and transient. The probability of each symptom was associated with a clear age-specific trend.

Side effects of 1% cyclopentolate hydrochloride in children and adolescents attended at Centro Universitário FMABC

INTRODUCTION: It is known that vision disorders are within the context of public health problems. In childhood, during the neuropsychomotor development phase, visual changes are crucial, since there is a strong correlation between poor school performance and changes in acuity. For these reasons, ophthalmological examination in children, including refraction, is extremely important, aiming at the early diagnosis of diseases and possible refractive errors that may compromise the child's life and development. 1% cyclopentolate hydrochloride eye drops are the most used during ophthalmic clinical evaluation as a cycloplegic and mydriatic agent to assist in refractive examination. OBJECTIVE: The ocular and systemic side effects of 1% cyclopentolate hydrochloride eye drops were studied in patients who underwent static refractive examination in the strabismus sector of the Ophthalmology Discipline of the Centro Universitário FMABC. METHODS: A drop of 1% cyclopentolate is instilled in both eyes of each patient and the possible ocular and systemic signs and symptoms presented were observed after 40 minutes and 24 hours after instillation. RESULTS: We expect to find ocular side effects more evident than systemic symptoms in the two evaluation times (40 minutes and 24 hours after instillation). All symptoms (ocular and systemic) are reversed spontaneously. CONCLUSION: The present study aims to show that the side effects observed by the topical (ocular) use of cyclopentolate eye drops 1% are few and present spontaneous reversal both from an eye point of view, as well as from a systemic point of view.

Delirium due to the use of topical cyclopentolate hydrochloride.

Introduction - Our aim is to present a rare case where a child had delirium manifestation after instillation of cyclopentolate. Case presentation - A 7-year old patient was seen in our outpatient clinic, and cyclopentolate was dropped three times at 10 minutes intervals in both eyes. The patient suddenly developed behavioral disorders along with gait disturbance, and complained of visual hallucinations 20-25 minutes after the last drop. The patient was transferred to intensive care unit and 0.02 mg/kg IV. physostigmine was administered. The patient improved after minutes of onset of physostigmine, and was discharged with total recovery after 30 minutes. Conclusion - Delirium is a rare systemic side effect of cyclopentolate. The specific antidote is physostigmine, which can be used in severely agitated patients who are not responding to other therapies.

Atrial arrhythmia after newborn eye exam, to caffeine or not to caffeine?

Mydriatic drops are routinely administered to premature neonates to screen for retinopathy of prematurity. Adverse anticholinergic side effects, particularly convulsions and tachycardia have been reported in the pediatric age group following instillation of mydriatics for diagnostic fundus examination [1, 2]. Caffeine is frequently used for apnea of prematurity. In the neonatal intensive care unit, the combined use of caffeine and mydriatic drops is a common practice. Here we report two cases of atrial arrhythmias after neonatal eye exam that improved with conservative management. Both patients were receiving caffeine at the time of events.

Systemic Absorption of Cyclopentolate and Adverse Events After Retinopathy of Prematurity Exams.

PURPOSE: Preterm infants undergoing Retinopathy of Prematurity Eye Exams (ROPEE) may experience adverse events, possibly from systemic absorption of cyclopentolate. The purpose of this study was to analyze the association between adverse events and drug levels found in neonates undergoing ROPEE. MATERIALS AND METHODS: 25 infants were randomized into two groups during routine ROP screening: 5 infants for blood collection before mydriatic drops and 20 for blood collection 1 h after eye drops. Blood was collected onto dried blood spot cards, extracted, and analyzed for cyclopentolate and phenylephrine using liquid chromatography and mass spectrometry. Relationships between drug levels and adverse events were assessed. RESULTS: Cyclopentolate (range 6-53 ng/ml) was observed in 15 of 18 infants, while phenylephrine was not detected. Levels of cyclopentolate were significantly higher in infants who were on oxygen (p = 0.01). There was a significant association between cyclopentolate levels and gastric residuals in tube-fed infants not receiving oxygen (p = 0.01). CONCLUSIONS: Cyclopentolate levels varied among preterm infants after ROPEE. Cyclopentolate was positively associated with increased gastric residuals. Underlying medical conditions requiring oxygen administration may affect absorption and metabolism of cyclopentolate. There is a need to predict infants at risk for high blood levels of cyclopentolate in order to prevent or treat adverse events after ROPEE.

Eficacia y seguridad de la midriasis farmacológica en prematuros / Efficacy and safety of pharmacological mydriasis in pre-term infants

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Adverse reactions following routine anticholinergic eye drops in a paediatric population: an observational cohort study.

OBJECTIVES: To investigate the presence, nature and relationship to age, sex, ethnicity and body mass index (BMI) of adverse reactions following routine cycloplegic eye drops in children. DESIGN: Prospective observational cohort study. SETTING: Ophthalmology outpatient clinic Dutch metropolitan hospital; February, March and April 2009. PARTICIPANTS: Children aged 3-14-year-old children receiving two drops of cyclopentolate 1% (C+C) or one drop of cyclopentolate 1% and one drop of tropicamide 1% (C+T). Patients were categorised by age (3-6, 7-10 and 11-14 years), sex, ethnicity and body mass index (BMI) (low, normal or high). OUTCOME MEASURES: Rate and nature of adverse reactions reported at 45 min following treatment. Crude and adjusted ORs for reporting an adverse reaction using stepwise regression analysis with BMI, age, ethnicity and sex. RESULTS: 912 of 915 eligible patients participated (99.7%). Adverse reactions were reported for C+C in 10.3% and in C+T in 4.8% (42/408 and 24/504, p=0.002), respectively. Central effects were present in 95% in C+C and in 92% in C+T. Compared to C+T, an increased risk was present in C+C (crude OR 2.3 (1.4 to 3.9), p=0.002). Forward adjustment showed BMI to be an influencing factor in treatment (OR 3.1 (1.7 to 5.6), p<0.001). In a multivariate model, a dose of cyclopentolate remained associated with adverse reactions. Analysis per BMI and regime and age category and regime, indicated associations with low BMI (OR C+C 21.4 (6.7 to 67.96), p<0.001, respectively, C+T 5.2 (2.1 to 12.8), p<0.001) and young age (OR C+C 8.1 (2.7 to 24.8), p<0.001). CONCLUSIONS: Adverse reactions were common and almost exclusively involved the central nervous system. Both presence and severity were associated with repeated instillation of cyclopentolate 1%, low BMI and young age. In specific paediatric populations, a single dose of cyclopentolate must be considered. Vital function monitoring facilities are advisable. Adjustment of guidelines is recommended.

Efficacy and safety of phenylephrine 2.5% with cyclopentolate 0.5% for retinopathy of prematurity screening in 1246 eye examinations.

PURPOSE: Retinopathy of prematurity (ROP) is a leading cause of visual loss in infancy that is largely preventable with careful screening. We report the safety and efficacy of the use of phenylephrine 2.5% and cyclopentolate 0.5% eyedrops instilled 3 times 5 minutes apart in ROP screening. METHODS: A total of 1246 ROP screening eye examinations were carried out by the same pediatric ophthalmologist between February 2011 and May 2013. Outcome measures were successful mydriasis (defined as achieving a full screening examination) and any intraprocedural systemic complications (defined as any respiratory, cardiac, or other clinical deterioration severe enough to result in screening abandonment). RESULTS: Of 1246 eyes, 1234 (98.8%) achieved successful dilation to enable complete screening. A fourth application was successful in the remaining 1.2%. No respiratory or cardiac arrest or any other intraprocedural event requiring cessation of screening was encountered during any of the examinations. No retinal bleeding or other intraocular complication occurred. CONCLUSIONS: This is the largest cohort studying the effectiveness and safety of a mydriatic regimen for ROP screening. We have found the combination of phenylephrine 2.5% with cyclopentolate 0.5% to be efficacious and well-tolerated. The absence of any severe intraprocedural complications may be related to reduced indentation time and stress in the infant facilitated by effective pupil dilation.

Focal seizures after instillation of cyclomydril to a neonate with congenital CMV infection.

We present the case of a term neonate who underwent a diagnostic eye examination on day one for possible genetic disorders. Five minutes after Cyclomydril (0.2% clyclopentolate and 1% phenylephrine) eye drops were instilled, a focal seizure lasting for approximately one hour occurred. The electroencephalograph (EEG) was normal but the magnetic resonance imaging (MRI) revealed calcifications in the bilateral periventricular regions. Urine CMV-DNA and maternal serum CMV-IgM were both positive. Auditory brainstem testing suggested severe sensoneural hearing loss. The baby was treated for congenital CMV infection and did not have further seizures. In this case the congenital CMV infection may have been the predisposing factor to central nervous system (CNS) toxicity induced by cyclopentolate. The exact mechanism is unknown but severe neurological impairment may be considered a contraindication for cyclopentolate eye drops in the neonate. To our knowledge, this is the first report of seizures occurring within the first week of life secondary to cyclomydril eye drops in a term neonate.

Fatal necrotising enterocolitis due to mydriatic eye drops.

Retinopathy of prematurity (ROP) is a serious problem of preterm infants which may lead to impairment of vision and even to blindness if untreated. Routine eye examination is necessary for early diagnosis and treatment of ROP in preterm infants. Mydriatic eye drops (cyclopentolate, tropicamide and phenylephrine) are applied before the ophthalmic examination. These agents are rarely absorbed to systemic circulation and in some cases result with serious side effects like skin rash, tachycardia, feeding intolerance, discomfort, apnea, gastric dilatation and ileus, despite different treatment models and dosage reducing strategies. We report here a preterm patient who died because of severe diffuse necrotizing enterocolitis (NEC) after topical application of 0.5% cyclopentolate and 1.25% phenylephrine during ROP screening to emphasise the serious side effects of these agents.

Cardiopulmonary arrest following administration of Cyclomydril eyedrops for outpatient retinopathy of prematurity screening.

Eyedrops used for mydriasis and cycloplegia can be systemically absorbed, causing serious side effects, including oxygen desaturation, apnea, bradycardia, transient hypertension, delayed gastric emptying, and transient paralytic ileus. These effects can be more serious in infants because of their lower body mass and immature cardiovascular and nervous systems. We report a case of a 27-week-old infant who suffered a cardiopulmonary arrest after the administration of only Cyclomydril eyedrops (Alcon Laboratories, Fort Worth, TX) during an outpatient retinopathy of prematurity examination.

Epileptic seizures induced by cycloplegic eye drops.

OBJECTIVE: To assess the incidence of seizures induced by cycloplegic ophthalmic drops. MATERIALS AND METHODS: A survey among members of the American Association for Pediatric Ophthalmology and Strabismus yielded five patients who received cycloplegic eye drops between 1998 and 2010 and who consequently developed a seizure. RESULTS: The median age of the patients was 5 years (range 3 months to 12 years). Cyclopentolate hydrochloride 1% was the only causative agent. The seizure happened on average 12 min after the instillation of dilating eye drops. Three were generalized convulsions, and two patients had a focal seizure. Past medical history was unremarkable in four cases. In total, 16 previous cases of seizures induced by cycloplegic drugs were identified in reports published between 1890 and 2004, implicating atropine in nine reports, tropicamide and phenylephrine eye drops in one and cyclopentolate in six. DISCUSSION: A small amount of cyclopentolate drops could induce convulsions in young children after only minutes to less than an hour, while a larger dosage of atropine over the span of several hours could cause this rare and unpredictable complication. Predisposing factors were rare and those developing the seizures were healthy subjects. Generalized seizures were much more frequent than focal convulsions. CONCLUSIONS: Seizures after instillation of cycloplegic drops are extremely rare.

Síndrome confusional agudo producido por instilación de ciclopléjico / Acute confusional syndrome after instillation cyclopentolate eye drops

Introducción: Se presentan dos casos de síndrome confusional agudo (SCA) secundarios a la administración de colirio de ciclopentolato en revisiones oftalmológicas de control. Pacientes: El caso 1 corresponde a un niño de 7 años de edad que presentó un eritema malar después de la administración del ciclopentolato y, posteriormente, un cuadro confusional agudo; tras las pruebas complementarias se concluyó que la causa del cuadro fue la instilación del colirio de ciclopentolato, y se mantuvo al paciente en observación. El caso 2 corresponde a un niño de 7 años de edad que acudió al servicio de urgencias por presentar clínica neurológica tras la instilación de colirio de ciclopentolato; no se realizaron pruebas complementarias y se mantuvo al niño en observación hasta el alta domiciliaria. Conclusiones: La administración de ciclopentolato en dosis habituales puede producir SCA en algunos niños. Si la clínica no es excesiva, sólo se requiere mantener a los pacientes en observación en el servicio de urgencias. En caso de cuadros graves, se puede utilizar como antídoto la fisostigmina(AU)

Introduction: We report two cases of acute confusional syndrome (ACS) after instillation cyclopentolate eye drops in usual doses during the regular ophthalmic checkups. Patients: Case 1: a seven year’s child who commenced to present malar erythema a half an hour later and after instilling cyclopentatolate; 2 hours later, the child presented an acute confusional state; after testing with complementary test was concluded that the cause was the cyclopentolate and the patient was under observation. Case 2: a seven year’s child who was admitted to the emergency service affected by neurological symptons after the instillation of the cyclopentalote eye drops 8 hours before; no additional tests were taken and the patient was under observation until the home discharge. Conclusions: The use of this drug in regular doses can produce ACS in some children. It is only required observation if the clinical use is not excessive. Can be administered physostigmine(AU)