title: Adverse reactions following routine anticholinergic eye drops in a paediatric population: an observational cohort study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Prospective observational cohort study.
  
  
  METHODS
  Ophthalmology outpatient clinic Dutch metropolitan hospital; February, March and April 2009.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
authors.affiliation: Department of Ophthalmology, Medical Centre Haaglanden, The Hague, The Netherlands.
authors.forename: Helena M
authors.initials: HM
authors.lastname: van Minderhout
authors.affiliation: Department of Ophthalmology, Medical Centre Haaglanden, The Hague, The Netherlands.
authors.forename: Maurits V
authors.initials: MV
authors.lastname: Joosse
authors.affiliation: Department of Research and Development, Landsteiner Institute, Medical Centre Haaglanden, The Hague, The Netherlands.
authors.forename: Diana C
authors.initials: DC
authors.lastname: Grootendorst
authors.affiliation: Department of Ophthalmology, Pediatric Ophthalmology, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: Nicoline E
authors.identifier: http://orcid.org/0000-0001-8979-7498
authors.initials: NE
authors.lastname: Schalij-Delfos
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D003519:Cyclopentolate / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D009184:Mydriatics / Q000008:administration & dosage / Q000009:adverse effects*; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D014331:Tropicamide / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D009184:Mydriatics; D009883:Ophthalmic Solutions; D003519:Cyclopentolate; D014331:Tropicamide
keywords: CLINICAL PHARMACOLOGY