Intrathecal baclofen trials: complications and positive yield in a pediatric cohort

Abstract

<jats:sec> <jats:title>OBJECT</jats:title> <jats:p>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).</jats:p></jats:sec> <jats:sec> <jats:title>METHODS</jats:title> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>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.</jats:p></jats:sec>

Should the Gross Motor Function Classification System be used for children who do not have cerebral palsy?

“…Twenty‐nine papers used the GMFCS only to describe participants . Eleven other papers used the GMFCS only to define eligibility criteria .…”

“…For example, ‘The GMFCS is used to classify locomotor skills of people with physical disabilities and can also be used with people with intellectual disabilities'; ‘In clinical practice, the [GMFCS] is also applied to children with other neuromotor impairments, such as acquired brain injuries or syndromes, as an indicator of functional mobility’ . Nine others used GMFCS ‘equivalent(s)’ for participants who did not have CP . Seven papers stated it was acceptable to use the GMFCS in other conditions/clinical descriptions without providing evidence of psychometric adequacy for these applications; another three explained that the GMFCS is used with children in general (not only children with CP) .…”

Intrathecal Baclofen Therapy for the Treatment of Spasticity in Sjögren-Larsson Syndrome

“…11,12 However, the Modified Ashworth Scale is widely used because it can be performed in a reasonably timely manner and due to its constant clinical availability. 13…”

Does Every Patient Require an Intrathecal Baclofen Trial Before Pump Placement?

“…We also must avoid doing harm. Several complications of ITB have been noted in many studies [4,5]. One of the major harms one might encounter would be a severe reaction to the medication, such as anaphylaxis or a respiratory complication.…”

“…Although ITB trialing is considered a relatively safe procedure, it is not completely risk‐free undertaking. The rate of complications during ITB trialing has been reported to be as high as 30%‐40% [7,8]. Adverse events may include nausea and vomiting, dizziness, paresthesia, drowsiness and sedation, spinal headaches, hypotonia, dizziness, paresthesia, hypotension, respiratory depression, infection, nausea/vomiting, urinary retention, hypotension, seizures, drowsiness/sedation, and coma.…”