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

Helena M van Minderhout¹, Maurits V Joosse¹, Diana C Grootendorst²

¹Department of Ophthalmology, Medical Centre Haaglanden, The Hague, The Netherlands.

|December 25, 2015

Insights

Adverse reactions to cycloplegic eye drops are common in children, particularly with repeated cyclopentolate doses. Low BMI and young age increase risks, suggesting single-dose consideration for certain pediatric patients.

Area of Science:

Ophthalmology
Pediatric Medicine
Clinical Pharmacology

Background:

Cycloplegic eye drops are routinely used in pediatric ophthalmology.
Adverse reactions can occur, but their prevalence and risk factors in children require further investigation.

Purpose of the Study:

To investigate the incidence, nature, and associations of adverse reactions following routine cycloplegic eye drops in children.
To explore the relationship between adverse reactions and patient factors like age, sex, ethnicity, and body mass index (BMI).

Main Methods:

Prospective observational cohort study involving children aged 3-14 years.
Children received either two drops of cyclopentolate 1% (C+C) or one drop each of cyclopentolate 1% and tropicamide 1% (C+T).
Adverse reactions were recorded, and statistical analyses (stepwise regression) were used to identify influencing factors.

Main Results:

Adverse reactions were reported in 10.3% of C+C and 4.8% of C+T groups, predominantly central nervous system effects.
Increased risk of adverse reactions was associated with C+C regimen (OR 2.3), low BMI (OR 3.1), and young age.
Low BMI and young age were significant risk factors, especially with the C+C regimen (ORs 21.4 and 8.1, respectively).

Conclusions:

Adverse reactions to cycloplegic eye drops in children are frequent, mainly affecting the central nervous system.
Repeated cyclopentolate instillation, low BMI, and young age are associated with increased risk.
Consideration of a single cyclopentolate dose and vital sign monitoring is recommended for specific pediatric populations.

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Abstract

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.

Keywords:

CLINICAL PHARMACOLOGY

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