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Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)

INTRODUCTION: Status epilepticus (SE) is a life-threatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as ‘refractory’ (RCSE) and requires intensive care unit treatment. There is currently neither evidence no...

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Autores principales: Rosati, Anna, Ilvento, Lucrezia, L'Erario, Manuela, De Masi, Salvatore, Biggeri, Annibale, Fabbro, Giancarlo, Bianchi, Roberto, Stoppa, Francesca, Fusco, Lucia, Pulitanò, Silvia, Battaglia, Domenica, Pettenazzo, Andrea, Sartori, Stefano, Biban, Paolo, Fontana, Elena, Cesaroni, Elisabetta, Mora, Donatella, Costa, Paola, Meleleo, Rosanna, Vittorini, Roberta, Conio, Alessandra, Wolfler, Andrea, Mastrangelo, Massimo, Mondardini, Maria Cristina, Franzoni, Emilio, McGreevy, Kathleen S, Di Simone, Lorena, Pugi, Alessandra, Mirabile, Lorenzo, Vigevano, Federico, Guerrini, Renzo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4916612/
https://www.ncbi.nlm.nih.gov/pubmed/27311915
http://dx.doi.org/10.1136/bmjopen-2016-011565
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author Rosati, Anna
Ilvento, Lucrezia
L'Erario, Manuela
De Masi, Salvatore
Biggeri, Annibale
Fabbro, Giancarlo
Bianchi, Roberto
Stoppa, Francesca
Fusco, Lucia
Pulitanò, Silvia
Battaglia, Domenica
Pettenazzo, Andrea
Sartori, Stefano
Biban, Paolo
Fontana, Elena
Cesaroni, Elisabetta
Mora, Donatella
Costa, Paola
Meleleo, Rosanna
Vittorini, Roberta
Conio, Alessandra
Wolfler, Andrea
Mastrangelo, Massimo
Mondardini, Maria Cristina
Franzoni, Emilio
McGreevy, Kathleen S
Di Simone, Lorena
Pugi, Alessandra
Mirabile, Lorenzo
Vigevano, Federico
Guerrini, Renzo
author_facet Rosati, Anna
Ilvento, Lucrezia
L'Erario, Manuela
De Masi, Salvatore
Biggeri, Annibale
Fabbro, Giancarlo
Bianchi, Roberto
Stoppa, Francesca
Fusco, Lucia
Pulitanò, Silvia
Battaglia, Domenica
Pettenazzo, Andrea
Sartori, Stefano
Biban, Paolo
Fontana, Elena
Cesaroni, Elisabetta
Mora, Donatella
Costa, Paola
Meleleo, Rosanna
Vittorini, Roberta
Conio, Alessandra
Wolfler, Andrea
Mastrangelo, Massimo
Mondardini, Maria Cristina
Franzoni, Emilio
McGreevy, Kathleen S
Di Simone, Lorena
Pugi, Alessandra
Mirabile, Lorenzo
Vigevano, Federico
Guerrini, Renzo
author_sort Rosati, Anna
collection PubMed
description INTRODUCTION: Status epilepticus (SE) is a life-threatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as ‘refractory’ (RCSE) and requires intensive care unit treatment. There is currently neither evidence nor consensus to guide either the optimal choice of therapy or treatment goals for RCSE, which is generally treated with coma induction using conventional anaesthetics (high dose midazolam, thiopental and/or propofol). Increasing evidence indicates that ketamine (KE), a strong N-methyl-d-aspartate glutamate receptor antagonist, may be effective in treating RCSE. We hypothesised that intravenous KE is more efficacious and safer than conventional anaesthetics in treating RCSE. METHODS AND ANALYSIS: A multicentre, randomised, controlled, open-label, non-profit, sequentially designed study will be conducted to assess the efficacy of KE compared with conventional anaesthetics in the treatment of RCSE in children. 10 Italian centres/hospitals are involved in enrolling 57 patients aged 1 month to 18 years with RCSE. Primary outcome is the resolution of SE up to 24 hours after withdrawal of therapy and is updated for each patient treated according to the sequential method. ETHICS AND DISSEMINATION: The study received ethical approval from the Tuscan Paediatric Ethics Committee (12/2015). The results of this study will be published in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT02431663; Pre-results.
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spelling pubmed-49166122016-06-24 Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01) Rosati, Anna Ilvento, Lucrezia L'Erario, Manuela De Masi, Salvatore Biggeri, Annibale Fabbro, Giancarlo Bianchi, Roberto Stoppa, Francesca Fusco, Lucia Pulitanò, Silvia Battaglia, Domenica Pettenazzo, Andrea Sartori, Stefano Biban, Paolo Fontana, Elena Cesaroni, Elisabetta Mora, Donatella Costa, Paola Meleleo, Rosanna Vittorini, Roberta Conio, Alessandra Wolfler, Andrea Mastrangelo, Massimo Mondardini, Maria Cristina Franzoni, Emilio McGreevy, Kathleen S Di Simone, Lorena Pugi, Alessandra Mirabile, Lorenzo Vigevano, Federico Guerrini, Renzo BMJ Open Neurology INTRODUCTION: Status epilepticus (SE) is a life-threatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as ‘refractory’ (RCSE) and requires intensive care unit treatment. There is currently neither evidence nor consensus to guide either the optimal choice of therapy or treatment goals for RCSE, which is generally treated with coma induction using conventional anaesthetics (high dose midazolam, thiopental and/or propofol). Increasing evidence indicates that ketamine (KE), a strong N-methyl-d-aspartate glutamate receptor antagonist, may be effective in treating RCSE. We hypothesised that intravenous KE is more efficacious and safer than conventional anaesthetics in treating RCSE. METHODS AND ANALYSIS: A multicentre, randomised, controlled, open-label, non-profit, sequentially designed study will be conducted to assess the efficacy of KE compared with conventional anaesthetics in the treatment of RCSE in children. 10 Italian centres/hospitals are involved in enrolling 57 patients aged 1 month to 18 years with RCSE. Primary outcome is the resolution of SE up to 24 hours after withdrawal of therapy and is updated for each patient treated according to the sequential method. ETHICS AND DISSEMINATION: The study received ethical approval from the Tuscan Paediatric Ethics Committee (12/2015). The results of this study will be published in peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT02431663; Pre-results. BMJ Publishing Group 2016-06-15 /pmc/articles/PMC4916612/ /pubmed/27311915 http://dx.doi.org/10.1136/bmjopen-2016-011565 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Neurology
Rosati, Anna
Ilvento, Lucrezia
L'Erario, Manuela
De Masi, Salvatore
Biggeri, Annibale
Fabbro, Giancarlo
Bianchi, Roberto
Stoppa, Francesca
Fusco, Lucia
Pulitanò, Silvia
Battaglia, Domenica
Pettenazzo, Andrea
Sartori, Stefano
Biban, Paolo
Fontana, Elena
Cesaroni, Elisabetta
Mora, Donatella
Costa, Paola
Meleleo, Rosanna
Vittorini, Roberta
Conio, Alessandra
Wolfler, Andrea
Mastrangelo, Massimo
Mondardini, Maria Cristina
Franzoni, Emilio
McGreevy, Kathleen S
Di Simone, Lorena
Pugi, Alessandra
Mirabile, Lorenzo
Vigevano, Federico
Guerrini, Renzo
Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)
title Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)
title_full Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)
title_fullStr Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)
title_full_unstemmed Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)
title_short Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)
title_sort efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (ketaser01)
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4916612/
https://www.ncbi.nlm.nih.gov/pubmed/27311915
http://dx.doi.org/10.1136/bmjopen-2016-011565
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