Management of severe spasticity in children is often a difficult problem. Orally administered medications generally offer limited benefits. This study examines the value of intrathecally administered
baclofen in the treatment of 19 children with severe spasticity of cerebral origin: eight of whom sustained
brain injury associated with
trauma,
near drowning, or
cardiac arrest; 10 with
cerebral palsy (spastic quadriplegia); and one child with
Leigh's disease. At the time of entry into the study, patients ranged from 4 to 19 years of age, and all were completely dependent on caretakers for
activities of daily living. Children who responded positively to a trial dose of intrathecal
baclofen underwent insertion of a drug delivery system for continuous infusion. This was followed by a double-blind trial of
baclofen or placebo and follow-up review at 3 and 6 months, and yearly thereafter. Seven children did not undergo pump implantation because of excess sedation or poor response. The 12 remaining children have been followed for a period of 1 to 5 years. Favorable responses were present in all 12 children as determined by the Ashworth Scale, with the greatest benefit being reduction of lower limb tone. Except in the case of one child who had reduction in lower limb tone that resulted in difficulty with transfers, the caretakers all reported significant benefits from intrathecal
baclofen, with improvement in muscle tone, behavior, sitting, and general ease of care being most commonly noted. Central side effects were seen in some children who received continuous intrathecal
baclofen infusion and included
hypotension (two patients),
bradycardia (two),
apnea or
respiratory depression (two), and sedation (one). During a total of 568 months of pump operation there were 10 mechanical complications, including two related to pump or side port failure and eight related to
catheter kinks, extrusions, or dislodgment. Pump pocket effusion occurred in five children and a cerebrospinal fluid
fistula was seen in one child. Local
infection occurred in three children and
meningitis in two children. The results demonstrate the potential value of continuous intrathecal
baclofen infusion for treatment of severe spasticity of cerebral origin. However, this treatment can result in significant complications and more experience is required before the long-term benefits can be determined.