KETASER01 protocol: What went right and what went wrong.

ABSTRACT:

Objective

To discuss the results of the KETASER01 trial and the reasons for its failure, particularly in view of future studies.

Methods

KETASER01 is a multicenter, randomized, controlled, open-label, sequentially designed, non-profit Italian study that aimed to assess the efficacy of ketamine compared with conventional anesthetics in the treatment of refractory convulsive status epilepticus (RCSE) in children.

Results

During the 5-year recruitment phase, a total of 76 RCSEs treated with third-line therapy were observed in five of the 10 participating Centers; only 10 individuals (five for each study arm; five females, mean age 6.5 ± 6.3 years) were enrolled in the KETASER01 study. Two of the five patients (40%) in the experimental arm were successfully treated with k

SUBMITTER: Rosati A 

PROVIDER: S-EPMC9436287 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature