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). JF - BMJ Open Y1 - 2016 A1 - Rosati, Anna A1 - Ilvento, Lucrezia A1 - L'Erario, Manuela A1 - De Masi, Salvatore A1 - Biggeri, Annibale A1 - Fabbro, Giancarlo A1 - Bianchi, Roberto A1 - Stoppa, Francesca A1 - Fusco, Lucia A1 - Pulitanò, Silvia A1 - Battaglia, Domenica A1 - Pettenazzo, Andrea A1 - Sartori, Stefano A1 - Biban, Paolo A1 - Fontana, Elena A1 - Cesaroni, Elisabetta A1 - Mora, Donatella A1 - Costa, Paola A1 - Meleleo, Rosanna A1 - Vittorini, Roberta A1 - Conio, Alessandra A1 - Wolfler, Andrea A1 - Mastrangelo, Massimo A1 - Mondardini, Maria Cristina A1 - Franzoni, Emilio A1 - McGreevy, Kathleen S A1 - Di Simone, Lorena A1 - Pugi, Alessandra A1 - Mirabile, Lorenzo A1 - Vigevano, Federico A1 - Guerrini, Renzo AB -

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.

VL - 6 IS - 6 U1 - http://www.ncbi.nlm.nih.gov/pubmed/27311915?dopt=Abstract ER -