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Adverse reactions to 1% cyclopentolate eye drops in children: an analysis using logistic regression models
Author(s) -
Imai Toshihiro,
Hasebe Satoshi,
Furuse Takashi,
Morisawa Shin,
Hasebe Kayoko,
Nagata Yuka,
Tokutake Tomoki,
Moriyama Yumiko
Publication year - 2021
Publication title -
ophthalmic and physiological optics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.147
H-Index - 66
eISSN - 1475-1313
pISSN - 0275-5408
DOI - 10.1111/opo.12773
Subject(s) - cyclopentolate , medicine , cycloplegia , logistic regression , odds ratio , anesthesia , adverse effect , confidence interval , eye drop , risk factor , pediatrics , refractive error , surgery , ophthalmology , eye disease
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.