title: Intrathecal baclofen trials: complications and positive yield in a pediatric cohort.
abstract: OBJECT Intrathecal baclofen (ITB) is an effective management option for childhood hypertonia. Given the potential complications of implanted ITB pumps, trials of ITB are usually performed as part of the workup for ITB pumps. Two methods are used for ITB trials, lumbar puncture (LP) and catheter insertion into the intrathecal space. Little has been written to date on the number of positive trials and complications in trials. This study aimed to report the outcomes and complications in ITB trials for childhood hypertonia (dystonia, spastic, or mixed). METHODS A retrospective case notes review was conducted of all patients who underwent ITB trials at the Evelina London Children's Hospital between 2005 and 2012 (inclusive). Positive trials were defined as a reduction in Modified Ashworth Scale by a minimum of 1 point in at least 2 muscle groups and improvement reported by the caregivers in the areas of goals agreed upon between professionals and the families. RESULTS Our patient group comprised children with dystonia (n = 7), mixed spasticity/dystonia (n = 29), spasticity (n = 4), and pain (n = 1). A total of 47 trials were attempted in 41 children. Forty trials were successfully completed, with 39 being positive. Thirty-three were catheter trials, and 14 were LPs. The overall complication rate in the 47 attempted trials was 53%: 61% in catheter trials, and 36% in LP trials. This difference was not statistically significant. The most common complications were vomiting (n = 9) and CSF leak (n = 4). The most serious complication was meningitis (n = 1) in a catheter trial. No patients experienced a permanent injury. CONCLUSIONS There is a high risk of minor self-limiting complications with ITB trials, which needs to be factored into the decision process of progression to trials. The rate of positive trials in this study was 98%, of which 21% did not progress to pump implantation. While the authors would still advocate for ITB trials prior to ITB pump insertion to aid parental decision-making, this figure suggests that with good patient selection, ITB pumps could be placed without a preceding trial.
authors.affiliation: Complex Motor Disorders Service, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust; and.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Sayer
authors.affiliation: Complex Motor Disorders Service, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust; and.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Lumsden
authors.affiliation: Complex Motor Disorders Service, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust; and.
authors.forename: Sarah
authors.initials: S
authors.lastname: Perides
authors.affiliation: Complex Motor Disorders Service, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust; and.
authors.forename: Kylee
authors.initials: K
authors.lastname: Tustin
authors.affiliation: Paediatric Neurosurgery, Kings' College Hospital, Kings' College Hospital NHS Foundation Trust, London, United Kingdom.
authors.forename: Sanj
authors.initials: S
authors.lastname: Bassi
authors.affiliation: Complex Motor Disorders Service, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust; and.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lin
authors.affiliation: Complex Motor Disorders Service, Evelina London Children's Hospital, Guy's and St. Thomas' NHS Foundation Trust; and.
authors.forename: Margaret
authors.initials: M
authors.lastname: Kaminska
keywords: CMDS = Complex Motor Disorders Service; GMFCS = Gross Motor Function Classification System; ITB = intrathecal baclofen; LP = lumbar puncture; MAS = Modified Ashworth Scale; baclofen; children; complications; dystonia; functional neurosurgery; intrathecal