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

Egunsola, Oluwaseun; Sammons, Helen M.; Ojha, Shalini; Whitehouse, William P.; Anderson, Mark; Hawcutt, Dan; Choonara, Imti

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Authors

Oluwaseun Egunsola

Helen M. Sammons

SHALINI OJHA Shalini.Ojha@nottingham.ac.uk
Professor of Neonatal Medicine

William P. Whitehouse

Mark Anderson

Dan Hawcutt

Imti Choonara



Abstract

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.

Journal Article Type Article
Acceptance Date Jul 13, 2017
Publication Date Aug 4, 2017
Deposit Date May 24, 2018
Publicly Available Date May 24, 2018
Journal BMJ Paediatrics Open
Electronic ISSN 2399-9772
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 1
Issue 1
Article Number 000116
DOI https://doi.org/10.1136/bmjpo-2017-000116
Public URL https://nottingham-repository.worktribe.com/output/876182
Publisher URL http://bmjpaedsopen.bmj.com/content/1/1/e000116

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