Adverse events associated with paediatric intrathecal baclofen in Australia: 5 years of data collection.

Aim: This study aims to examine the adverse event (AE) rate for intrathecal baclofen (ITB) therapy in an Australian paediatric population and to clarify type and frequency of AEs.

Methods: AE data were extracted from the Australian Paediatric ITB Research Group national database, to include the first 5 years of data collection. Raw data were collated and analysed descriptively.

Results: Data were collected for 40 patients. Forty-seven AEs in 23 patients were reported. Ten (25%) patients required surgical intervention related to their AE. Five patients (12.5%) required pump removal. The most frequent ITB-related AEs were catheter dysfunction (24%), drug overdose, withdrawal or sensitivity (19%), seromas and haematomas (15%) and infections (13%).

Conclusions: The AE rate for ITB therapy is high and needs to be considered when counselling patients regarding ITB as a therapeutic option.