The Most Bizarre FK228 Story
Added: (Sun Mar 19 2017)
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Eligibility criteria Inclusion criteria Patients are eligible if (1) they are aged 1?month to 18?years of age; (2) they present with SE refractory to first-line (benzodiazepines by GNAT2 mouth or by rectum) and second-line (phenytoin 20?mg/kg and/or phenobarbital 20?mg/kg and MDZ up to 6??g/kg/min) AEDs; (3) their parents provide written consent. Exclusion criteria Patients will be excluded if (1) they have a contraindication to the use of any of the drugs in the study protocol; (2) they have a presumed or ascertained pregnancy status; (3)
they had already been enrolled in the KETASER01 study for an antecedent RCSE episode. Patients with RCSE unresponsive to first-line and second-line drugs will be transferred from the neurological department to the ICU. They will be enrolled in the study by the neurologist NVP-BGJ398 datasheet and anaesthesiologist in the ICU, after assessing the eligibility criteria and obtaining informed consent
from their parents. Interventions The experimental arm: KE KE is administered starting with an initial bolus of 2�C3?mg/kg followed by continuous infusion of 10??g/kg/min, increasing the infusion rate by 5�C10??g/kg/min every 10?min up to a maximum of 100??g/kg/min, with every increment being preceded by a bolus of 1�C2?mg/kg. KE is always administered in association with 2�C4??g/kg/min MDZ. For patients treated with continuous infusion of MDZ (second-line therapy) for <5?days, the dosage of the benzodiazepine is reduced from 6 to 2??g/kg/min, to prevent emergence reactions. For patients treated with MDZ for 5 or more days, the dose of the benzodiazepine is reduced from 6 to 3�C4??g/kg/min to avoid seizure occurrence secondary to abrupt benzodiazepine withdrawal and prevent emergence reactions.19 Dosages above 4??g/kg/min, although previously not efficacious, could interfere with
learn more the evaluation of the effectiveness of KE. In case of RCSE resolution, the effective dosage of KE is continued for a minimum of 48?hours up to a maximum of 7?days, based on the EEG features of a continuous recording analysed by a neurologist. In the case of no response (persistence of SE at the maximum treatment dose) or adverse events, the drug is discontinued and treatment failure is declared. KE is discontinued gradually by reducing the starting dose by 25% every 12?hours for infusion dosages between 50 and 100??g/kg/min; withdrawal may be more rapid (25% of the starting dose every 6?hours) for dosages <50??g/kg/min or a shorter duration of infusion (48?hours; see figure 1). Figure?1 Flow chart. MDZ, midazolam; KE, ketamine; PR, propofol; TPS, thiopental. The control arm: MDZ and (TPS and/or PR) The administration of conventional anaesthetics for the treatment of RCSE follows the current guidelines that consider MDZ at anaesthetic dosage as the first therapeutic option, followed by PR and/or TPS. The decision to administer PR or TPS first is at the clinician's discretion.