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Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy.
Eur J Paediatr Neurol. 2009 May; 13(3):247-56.EJ

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.

AIMS

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+Show Affiliations

Department of Neurology, University Hospital Maastricht, The Netherlands. mahoving@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18590974

Citation

Hoving, Marjanke A., et al. "Safety and One-year Efficacy of Intrathecal Baclofen Therapy in Children With Intractable Spastic Cerebral Palsy." European Journal of Paediatric Neurology : EJPN : Official Journal of the European Paediatric Neurology Society, vol. 13, no. 3, 2009, pp. 247-56.
Hoving MA, van Raak EP, Spincemaille GH, et al. Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy. Eur J Paediatr Neurol. 2009;13(3):247-56.
Hoving, M. A., van Raak, E. P., Spincemaille, G. H., van Kranen-Mastenbroek, V. H., van Kleef, M., Gorter, J. W., & Vles, J. S. (2009). Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy. European Journal of Paediatric Neurology : EJPN : Official Journal of the European Paediatric Neurology Society, 13(3), 247-56. https://doi.org/10.1016/j.ejpn.2008.05.002
Hoving MA, et al. Safety and One-year Efficacy of Intrathecal Baclofen Therapy in Children With Intractable Spastic Cerebral Palsy. Eur J Paediatr Neurol. 2009;13(3):247-56. PubMed PMID: 18590974.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and one-year efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy. AU - Hoving,Marjanke A, AU - van Raak,Elisabeth P M, AU - Spincemaille,Geert H J J, AU - van Kranen-Mastenbroek,Vivianne H J M, AU - van Kleef,Maarten, AU - Gorter,Jan Willem, AU - Vles,Johan S H, AU - ,, Y1 - 2008/06/30/ PY - 2007/12/03/received PY - 2008/05/06/accepted PY - 2008/7/2/pubmed PY - 2009/7/2/medline PY - 2008/7/2/entrez SP - 247 EP - 56 JF - European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society JO - Eur J Paediatr Neurol VL - 13 IS - 3 N2 - 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. AIMS: 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. SN - 1532-2130 UR - https://www.unboundmedicine.com/medline/citation/18590974/Safety_and_one_year_efficacy_of_intrathecal_baclofen_therapy_in_children_with_intractable_spastic_cerebral_palsy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1090-3798(08)00103-7 DB - PRIME DP - Unbound Medicine ER -