TY - JOUR
T1 - 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)
AU - Pulitano', Silvia Maria
AU - Battaglia, Domenica Immacolata
AU - Bianchi, Roberto
AU - Rosati, Anna
AU - Ilvento, Lucrezia
AU - L'Erario, Manuela
AU - Masi, Salvatore De
AU - Biggeri, Annibale
AU - Fabbro, Giancarlo
AU - Stoppa, Francesca
AU - Fusco, Lucia
AU - Pettenazzo, Andrea
AU - Sartori, Stefano
AU - Biban, Paolo
AU - Fontana, Elena
AU - Cesaroni, Elisabetta
AU - Mora, Donatella
AU - Costa, Paola
AU - Meleleo, Rosanna
AU - Vittorini, Roberta
AU - Conio, Alessandra
AU - Wolfler, Andrea
AU - Mastrangelo, Massimo
AU - Mondardini, Maria Cristina
AU - Franzoni, Emilio
AU - Mcgreevy, Kathleen S.
AU - Simone, Lorena Di
AU - Pugi, Alessandra
AU - Mirabile, Lorenzo
AU - Vigevano, Federico
AU - Guerrini, Renzo
PY - 2016
Y1 - 2016
N2 - Introduction: Status epilepticus (SE) is a lifethreatening 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.
AB - Introduction: Status epilepticus (SE) is a lifethreatening 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.
KW - Medicine (all)
KW - Medicine (all)
UR - http://hdl.handle.net/10807/95284
UR - http://bmjopen.bmj.com/content/early/by/section
U2 - 10.1136/bmjopen-2016-011565
DO - 10.1136/bmjopen-2016-011565
M3 - Article
VL - 6
SP - N/A-N/A
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
ER -