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

Abstract

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. (© 2020 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)11: CD004552.; Butler C, Campbell S. Evidence of the effects of intrathecal baclofen for spastic and dystonic cerebral palsy. Dev. Med. Child Neurol. 2000; 42: 634-45.; Davidoff RA. Antispasticity drugs: Mechanisms of action. Ann. Neurol. 1985; 17: 107-16.; Ertzgaard P, Campo C, Calabrese A. Efficiency and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen. J. Rehabil. Med. 2017; 49: 193-203.; Motta F, Antonello CE. Analysis of complications in 430 consecutive pediatric patients treated with intrathecal baclofen therapy: 14-year experience. J. Neurosurg. Pediatr. 2014; 13: 301-6.; Borowski A, Littleton AG, Borkhuu B et al. Complications of intrathecal baclofen pump therapy in pediatric patients. J. Pediatr. Orthop. 2010; 30: 76-81.; Watve SV, Sivan M, Raza WA, Jamil FF. Management of acute overdose or withdrawal state in intrathecal baclofen therapy. Spinal Cord 2012; 50: 107-11.; Mohammed I, Hussain A. Intrathecal baclofen withdrawal syndrome - A life-threatening complication of baclofen pump: A case report. BMC Clin. Pharmacol. 2004; 4: 6.; Liew PY, Stewart K, Khan D, Arnup SJ, Scheinberg A. Intrathecal baclofen therapy in children: An analysis of individualised goals. Dev. Med. Child Neurol. 2018; 60: 367-73.; Ward A, Hayden S, Dexter M, Sheinberg A. Continuous intrathecal baclofen for children with spasticity and/or dystonia: Gaol attainment and complication associated with treatment. J. Paediatr. Child Health 2009; 45: 720-6.; Kraus T, Gegenleitner K, Svehlik M, Novak M, Steinwender G, Singer G. Long-term therapy with intrathecal baclofen improves quality of life in children with severe spastic cerebral palsy. Eur. J. Paediatr. Neurol. 2017; 21: 565-9.; Stewart K, Hutana G, Kentish M. Intrathecal baclofen therapy in paediatrics: A study protocol for an Australian multi-centre, 10 year, prospective audit. BMJ Open 2017; 7: e015863.; Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev. Med. Child Neurol. 1997; 39: 214-23.; Buizer A, Martens BHM, van Ravenhorst CG, Schoonmade LJ, Becher JG, Vermeulen RJ. Effect of continuous intrathecal baclofen therapy in children: A systematic review. Dev. Med. Child Neurol. 2019; 61: 128-34.; Zdolsek H, Olesch C, Antolovich G, Reddihough D. Intrathecal baclofen therapy: Benefits and complications. J. Intellect. Dev. Disabil. 2011; 36: 207-13.; Dastgir A, Ranalli NJ, MacGregor TL, Aldana PR. Baclofen pump catheter leakage after migration of the abdominal catheter in a pediatric patient with spasticity. J. Neurosurg. Pediatr. 2015; 16: 335-9.; Swinney CM, Bau K, Burton KLO, O'Flaherty SJ, Bear NL, Paget SP. Severity of cerebral palsy and likelihood of adverse events after botulinum toxin A injections. Dev. Med. Child Neurol. 2018; 60: 498-504.; Naidu K, Smith K, Sheedy M, Adair B, Yu X, Graham HK. Systemic adverse events following botulinum toxin A therapy in children with cerebral palsy. Dev. Med. Child Neurol. 2010; 52: 139-44.. Linking ISSN: 10344810. Subset: MEDLINE; Grant Information: Children's Health Queensland Study, Education and Research Trust (SERTA) grant Date of Electronic Publication: 2020 Sep 25. ; Original Imprints: Publication: Melbourne ; Boston : Blackwell Scientific Publications, c1990- <br />