#Eset trial trial
Trial drugs were identical in appearance, formulation, packaging, and administration, including the total volume in the vial and duration of infusion.Multicenter randomized clinical trial increasing external validity.There are a couple of prior studies on pediatric status epilepticus, but not much of anything on adults.Numerically more episodes of hypotension and intubation occurred in the fosphenytoin group (3.2% and 26.4% respectively) and more deaths occurred in the levetiracetam group (4.7%) than in the other groups ( The differences were not statistically significant).Median Duration of Seizure at Enrollment (IQR):.Cessation of Status Epilepticus at 60min:.Cessation of Status Epilepticus & Improvement in Level of Consciousness at 60min:.16 patients enrolled twice and not included in intention-to-treat analysis.400 patients enrolled of which 384 patients were unique.Known allergy or contraindications to any of the trial drugs.
Already been treated for the current episode of status epilepticus with anticonvulsant agents other than benzodiazepines.Acute precipitant of seizure was major trauma, hypoglycemia, hyperglycemia, cardiac arrest, or postanoxia.No more than 30 minutes after the last dose of benzodiazepine.At least 5 minutes after the last dose of benzodiazepine.5 minutes, and continued to have persistent or recurrent convulsions in the ED plus….≥32kg = Diazepam at a dose of 10mg (IV or IM), lorazepam at a dose of 4mg (IV), or midazolam at a dose of 10mg (IV or IM).The minimal adequate cumulative doses of benzodiazepines were defined as:.Using adaptive randomization allows for a lower than expected sample size with a higher power while having a high probability of randomizing a higher proportion of patients to the most effective therapy. This is done with multiple interim analyses to randomize more patients to the treatment that is most likely to be effective. Response Adaptive: This allows the ability to calculate the probability that each treatment is the best or worst possibility.Therefore, a much larger sample size is needed for adequate power which results in a longer and/or more expensive trial. Comparative Effectiveness Trials: When comparing commercially available products in a heterogenous population the results are typically very small in effect size (Smaller than you would expect with something compared to placebo).In researching this I found it fascinating and thought I would share with others… Before everyone freaks out, I had to look this up to understand what this even meant.Patients enrolled at 57 emergency departments across the USĪ Word on Response-Adaptive Comparative-Effectiveness Trial Design:.Compared efficacy and safety of 3 IV anticonvulsive agents: levetiracetam, fosphenytoin, and valproate in benzodiazepine refractory patients.Multicenter, randomized, blinded, comparative effectiveness trial.
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