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.