title: Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy.
abstract: BACKGROUND
  Prospective studies that address both efficacy and safety of continuous infusion of intrathecal baclofen (CITB) in children with spastic cerebral palsy (CP), and that use outcome measures beyond muscle tone are lacking.
  
  
  OBJECTIVE
  To study the efficacy at 12 months and safety up to 24 months after start of CITB in children with intractable spastic CP.
  
  
  METHODS
  Nine girls and eight boys, aged 13.7 years (SD 2.9), received a SynchroMed pump for CITB. We prospectively recorded effects and adverse events at regular follow-up visits up to 24 months. Outcome measures included the 0-10 visual analogue scale (VAS) for individual problems, Gross Motor Function Measure (GMFM) and health related quality of life as measured with the Child Health Questionnaire-PF50.
  
  
  RESULTS
  CITB for 12 months significantly improved the VAS for individual problems with 4.7 (SD 2.0; p=0.000), VAS for ease of care with 5.2 (SD 2.1; p=0.000), VAS for pain with 5.4 (SD 2.7; p=0.002); GMFM sitting dimension with 3.3 (range -4.0 to 22.0; p=0.022), GMFM goal dimension with 4.0 (range 0.0-26.0; p=0.007); and Child Health Questionnaire-PF50 domains of bodily pain/discomfort with 25.6 (SD 35.9; p=0.016) and mental health with 9.8 (SD 11.3; p=0.007). During a mean follow-up of 18.4 months (range 12-24), we recorded 80 adverse events. Eight adverse events were serious, but not life-threatening.
  
  
  CONCLUSIONS
  CITB was effective at 12 months and safe up to 24 months for carefully selected children with intractable spastic CP. CITB relieved pain, facilitated ease of care and improved mental health. The majority of children could extend their activities and participation.
authors.affiliation: Department of Neurology, University Hospital Maastricht, The Netherlands. mahoving@hotmail.com
authors.forename: Marjanke A
authors.initials: MA
authors.lastname: Hoving
authors.forename: Elisabeth P M
authors.initials: EP
authors.lastname: van Raak
authors.forename: Geert H J J
authors.initials: GH
authors.lastname: Spincemaille
authors.forename: Vivianne H J M
authors.initials: VH
authors.lastname: van Kranen-Mastenbroek
authors.forename: Maarten
authors.initials: M
authors.lastname: van Kleef
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: Gorter
authors.forename: Johan S H
authors.initials: JS
authors.lastname: Vles
mesh_terms: D000293:Adolescent; D001418:Baclofen / Q000008:administration & dosage* / Q000009:adverse effects*; D002547:Cerebral Palsy / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015918:Infusion Pumps, Implantable; D007278:Injections, Spinal; D008297:Male; D008603:Mental Health; D009125:Muscle Relaxants, Central / Q000008:administration & dosage* / Q000009:adverse effects*; D010146:Pain / Q000139:chemically induced / Q000503:physiopathology; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D009125:Muscle Relaxants, Central; D001418:Baclofen