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Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study.
Dev Med Child Neurol. 2007 Sep; 49(9):654-9.DM

Abstract

Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB infusion, to assess the effective ITB bolus dose, and to evaluate the effects, side effects, and complications. Outcome measures included the original Ashworth scale and the Visual Analogue Scale for individually formulated problems. We studied nine females and eight males, aged between 7 and 16 years (mean age 13y 2mo [SD 2y 9mo]). Twelve children had spastic CP and five had spastic-dyskinetic CP. One child was classified on the Gross Motor Function Classification System at Level III, two at Level I V, and 14 at Level V. The test treatment worked successfully for all 17 children with an effective ITB bolus dose of 12.5 microg in one, 20 microg in another, 25 microg in 10, and 50 microg in five children. ITB significantly reduced muscle tone, diminished pain, and facilitated ease of care. The placebo did not have these effects. Nine side effects of ITB were registered, including slight lethargy in seven children. Fourteen children had symptoms of lowered cerebrospinal fluid pressure. We conclude that ITB bolus administration is effective and safe for carefully selected children with intractable spastic CP.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

17718820

Citation

Hoving, Marjanke A., et al. "Intrathecal Baclofen in Children With Spastic Cerebral Palsy: a Double-blind, Randomized, Placebo-controlled, Dose-finding Study." Developmental Medicine and Child Neurology, vol. 49, no. 9, 2007, pp. 654-9.
Hoving MA, van Raak EP, Spincemaille GH, et al. Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study. Dev Med Child Neurol. 2007;49(9):654-9.
Hoving, M. A., van Raak, E. P., Spincemaille, G. H., Palmans, L. J., Sleypen, F. A., & Vles, J. S. (2007). Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study. Developmental Medicine and Child Neurology, 49(9), 654-9.
Hoving MA, et al. Intrathecal Baclofen in Children With Spastic Cerebral Palsy: a Double-blind, Randomized, Placebo-controlled, Dose-finding Study. Dev Med Child Neurol. 2007;49(9):654-9. PubMed PMID: 17718820.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intrathecal baclofen in children with spastic cerebral palsy: a double-blind, randomized, placebo-controlled, dose-finding study. AU - Hoving,Marjanke A, AU - van Raak,Elisabeth P M, AU - Spincemaille,Geert H J J, AU - Palmans,Liesbeth J, AU - Sleypen,Frans A M, AU - Vles,Johan S H, AU - ,, PY - 2007/8/28/pubmed PY - 2007/10/3/medline PY - 2007/8/28/entrez SP - 654 EP - 9 JF - Developmental medicine and child neurology JO - Dev Med Child Neurol VL - 49 IS - 9 N2 - Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double-blind, randomized, placebo-controlled, dose-finding study were to select children eligible for continuous ITB infusion, to assess the effective ITB bolus dose, and to evaluate the effects, side effects, and complications. Outcome measures included the original Ashworth scale and the Visual Analogue Scale for individually formulated problems. We studied nine females and eight males, aged between 7 and 16 years (mean age 13y 2mo [SD 2y 9mo]). Twelve children had spastic CP and five had spastic-dyskinetic CP. One child was classified on the Gross Motor Function Classification System at Level III, two at Level I V, and 14 at Level V. The test treatment worked successfully for all 17 children with an effective ITB bolus dose of 12.5 microg in one, 20 microg in another, 25 microg in 10, and 50 microg in five children. ITB significantly reduced muscle tone, diminished pain, and facilitated ease of care. The placebo did not have these effects. Nine side effects of ITB were registered, including slight lethargy in seven children. Fourteen children had symptoms of lowered cerebrospinal fluid pressure. We conclude that ITB bolus administration is effective and safe for carefully selected children with intractable spastic CP. SN - 0012-1622 UR - https://www.unboundmedicine.com/medline/citation/17718820/Intrathecal_baclofen_in_children_with_spastic_cerebral_palsy:_a_double_blind_randomized_placebo_controlled_dose_finding_study_ L2 - https://doi.org/10.1111/j.1469-8749.2007.00654.x DB - PRIME DP - Unbound Medicine ER -