%0 Journal Article %J BMJ Open %D 2016 %T 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). %A Rosati, Anna %A Ilvento, Lucrezia %A L'Erario, Manuela %A De Masi, Salvatore %A Biggeri, Annibale %A Fabbro, Giancarlo %A Bianchi, Roberto %A Stoppa, Francesca %A Fusco, Lucia %A Pulitanò, Silvia %A Battaglia, Domenica %A Pettenazzo, Andrea %A Sartori, Stefano %A Biban, Paolo %A Fontana, Elena %A Cesaroni, Elisabetta %A Mora, Donatella %A Costa, Paola %A Meleleo, Rosanna %A Vittorini, Roberta %A Conio, Alessandra %A Wolfler, Andrea %A Mastrangelo, Massimo %A Mondardini, Maria Cristina %A Franzoni, Emilio %A McGreevy, Kathleen S %A Di Simone, Lorena %A Pugi, Alessandra %A Mirabile, Lorenzo %A Vigevano, Federico %A Guerrini, Renzo %X

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.

%B BMJ Open %V 6 %P e011565 %8 2016 %G eng %N 6 %1 http://www.ncbi.nlm.nih.gov/pubmed/27311915?dopt=Abstract %R 10.1136/bmjopen-2016-011565 %0 Journal Article %J Eur J Paediatr Neurol %D 2014 %T Long-term follow-up in children with benign convulsions associated with gastroenteritis. %A Verrotti, Alberto %A Moavero, Romina %A Vigevano, Federico %A Cantonetti, Laura %A Guerra, Azzurra %A Spezia, Elisabetta %A Tricarico, Antonella %A Nanni, Giuliana %A Agostinelli, Sergio %A Chiarelli, Francesco %A Parisi, Pasquale %A Capovilla, Giuseppe %A Beccaria, Francesca %A Spalice, Alberto %A Coppola, Giangennaro %A Franzoni, Emilio %A Gentile, Valentina %A Casellato, Susanna %A Veggiotti, Pierangelo %A Malgesini, Sara %A Crichiutti, Giovanni %A Balestri, Paolo %A Grosso, Salvatore %A Zamponi, Nelia %A Incorpora, Gemma %A Savasta, Salvatore %A Costa, Paola %A Pruna, Dario %A Cusmai, Raffaella %K Adolescent %K Anticonvulsants %K Attention Deficit Disorder with Hyperactivity %K Child %K Child, Preschool %K Electroencephalography %K Epilepsy %K Female %K Gastroenteritis %K Humans %K Longitudinal Studies %K Male %K Neurologic Examination %K Retrospective Studies %X

BACKGROUND: The outcome of benign convulsions associated with gastroenteritis (CwG) has generally been reported as being excellent. However, these data need to be confirmed in studies with longer follow-up evaluations.

AIM: To assess the long-term neurological outcome of a large sample of children presenting with CwG.

METHODS: We reviewed clinical features of 81 subjects presenting with CwG (1994-2010) from three different Italian centers with a follow-up period of at least 3 years.

RESULTS: Follow-up period ranged from 39 months to 15 years (mean 9.8 years). Neurological examination and cognitive level at the last evaluation were normal in all the patients. A mild attention deficit was detected in three cases (3.7%). Fourteen children (17.3%) received chronic anti-epileptic therapy. Interictal EEG abnormalities detected at onset in 20 patients (24.7%) reverted to normal. Transient EEG epileptiform abnormalities were detected in other three cases (3.7%), and a transient photosensitivity in one (1.2%). No recurrence of CwG was observed. Three patients (3.7%) presented with a febrile seizure and two (2.5%) with an unprovoked seizure, but none developed epilepsy.

CONCLUSIONS: The long-term evaluation of children with CwG confirms the excellent prognosis of this condition, with normal psychomotor development and low risk of relapse and of subsequent epilepsy.

%B Eur J Paediatr Neurol %V 18 %P 572-7 %8 2014 Sep %G eng %N 5 %1 http://www.ncbi.nlm.nih.gov/pubmed/24780603?dopt=Abstract %R 10.1016/j.ejpn.2014.04.006