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Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting

This retrospective study aimed to examine the safety of botulinum toxin A (BoNT-A) treatment in a paediatric multidisciplinary cerebral palsy clinic. In a sample of 454 patients who had 1515 BoNT-A sessions, data on adverse events were available in 356 patients and 1382 sessions; 51 non-fatal advers...

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Autores principales: Papavasiliou, Antigone S., Nikaina, Irene, Foska, Katerina, Bouros, Panagiotis, Mitsou, George, Filiopoulos, Constantine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3705276/
https://www.ncbi.nlm.nih.gov/pubmed/23482250
http://dx.doi.org/10.3390/toxins5030524
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author Papavasiliou, Antigone S.
Nikaina, Irene
Foska, Katerina
Bouros, Panagiotis
Mitsou, George
Filiopoulos, Constantine
author_facet Papavasiliou, Antigone S.
Nikaina, Irene
Foska, Katerina
Bouros, Panagiotis
Mitsou, George
Filiopoulos, Constantine
author_sort Papavasiliou, Antigone S.
collection PubMed
description This retrospective study aimed to examine the safety of botulinum toxin A (BoNT-A) treatment in a paediatric multidisciplinary cerebral palsy clinic. In a sample of 454 patients who had 1515 BoNT-A sessions, data on adverse events were available in 356 patients and 1382 sessions; 51 non-fatal adverse events were reported (3.3% of the total injections number, 8.7% of the patients). On five occasions, the adverse reactions observed in GMFCS V children were attributed to the sedation used (rectal midazolam plus pethidine; buccal midazolam) and resulted in prolongation of hospitalization. Of the reactions attributed to the toxin, 23 involved an excessive reduction of the muscle tone either of the injected limb(s) or generalized; others included local pain, restlessness, lethargy with pallor, disturbance in swallowing and speech production, seizures, strabismus, excessive sweating, constipation, vomiting, a flu-like syndrome and emerging hypertonus in adjacent muscles. Their incidence was associated with GMFCS level and with the presence of epilepsy (Odds ratio (OR) = 2.74 − p = 0.016 and OR = 2.35 − p = 0.046, respectively) but not with BoNT-A dose (either total or per kilogram). In conclusion, treatment with BoNT-A was safe; adverse reactions were mostly mild even for severely affected patients. Their appearance did not necessitate major changes in our practice.
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spelling pubmed-37052762013-07-09 Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting Papavasiliou, Antigone S. Nikaina, Irene Foska, Katerina Bouros, Panagiotis Mitsou, George Filiopoulos, Constantine Toxins (Basel) Article This retrospective study aimed to examine the safety of botulinum toxin A (BoNT-A) treatment in a paediatric multidisciplinary cerebral palsy clinic. In a sample of 454 patients who had 1515 BoNT-A sessions, data on adverse events were available in 356 patients and 1382 sessions; 51 non-fatal adverse events were reported (3.3% of the total injections number, 8.7% of the patients). On five occasions, the adverse reactions observed in GMFCS V children were attributed to the sedation used (rectal midazolam plus pethidine; buccal midazolam) and resulted in prolongation of hospitalization. Of the reactions attributed to the toxin, 23 involved an excessive reduction of the muscle tone either of the injected limb(s) or generalized; others included local pain, restlessness, lethargy with pallor, disturbance in swallowing and speech production, seizures, strabismus, excessive sweating, constipation, vomiting, a flu-like syndrome and emerging hypertonus in adjacent muscles. Their incidence was associated with GMFCS level and with the presence of epilepsy (Odds ratio (OR) = 2.74 − p = 0.016 and OR = 2.35 − p = 0.046, respectively) but not with BoNT-A dose (either total or per kilogram). In conclusion, treatment with BoNT-A was safe; adverse reactions were mostly mild even for severely affected patients. Their appearance did not necessitate major changes in our practice. MDPI 2013-03-12 /pmc/articles/PMC3705276/ /pubmed/23482250 http://dx.doi.org/10.3390/toxins5030524 Text en © 2013 by the authors; licensee MDPI, Basel, Switzerland. http://creativecommons.org/licenses/by/3.0/ This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/).
spellingShingle Article
Papavasiliou, Antigone S.
Nikaina, Irene
Foska, Katerina
Bouros, Panagiotis
Mitsou, George
Filiopoulos, Constantine
Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting
title Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting
title_full Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting
title_fullStr Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting
title_full_unstemmed Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting
title_short Safety of Botulinum Toxin A in Children and Adolescents with Cerebral Palsy in a Pragmatic Setting
title_sort safety of botulinum toxin a in children and adolescents with cerebral palsy in a pragmatic setting
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3705276/
https://www.ncbi.nlm.nih.gov/pubmed/23482250
http://dx.doi.org/10.3390/toxins5030524
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