Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK

Egunsola, Oluwaseun and Sammons, Helen M. and Ojha, Shalini and Whitehouse, William P. and Anderson, Mark and Hawcutt, Dan and Choonara, Imti (2017) Protocol for a prospective observational study of adverse drug reactions of antiepileptic drugs in children in the UK. BMJ Paediatrics Open, 1 (1). 000116/1-000116/7. ISSN 2399-9772

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Background Epilepsy is a common chronic disease of children that can be treated with anti-epileptic drugs (AEDs). AEDs, however, have significant side effects. Newer AEDs are thought to have fewer side effects. There have, however, been few comparative studies of AED toxicity. The aim is to compare the safety profile of the most frequently used AEDs by performing a multicentre prospective cohort study. This protocol describes the planned study.

Design A multicentre prospective cohort study of children on AED treatment in hospitals across the UK. Ethical approval will be obtained.

Sample size Three thousand children on treatment for epilepsy will be recruited from paediatric clinics. It is expected that this sample size will have the potential to compare toxicity between the most frequently used AEDs.

Duration of study 24 months.

Outcome measure Adverse drug reactions (ADRs) to AEDs. These will be identified by the use of a validated questionnaire, the Paediatric Epilepsy Side Effect Questionnaire. They will be evaluated using the Naranjo algorithm. Preventability will be assessed using the Schumock and Thornton scale.

Discussion Toxicity of individual AEDs when given as monotherapy and polytherapy will be determined. Additionally, discontinuation rates due to ADRs will be determined. The data will assist clinicians in choosing AEDs with the least toxicity.

Item Type: Article
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Child Health, Obstetrics and Gynaecology
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Depositing User: Shreeve, Claire
Date Deposited: 24 May 2018 07:21
Last Modified: 02 Jul 2018 09:20

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