Open AccessKETASER01 protocol: What went right and what went wrong
Author(s) -
Rosati Anna,
L’Erario Manuela,
Bianchi Roberto,
Olivotto Sara,
Battaglia Domenica Immacolata,
Darra Francesca,
Biban Paolo,
Biggeri Annibale,
Catelan Dolores,
Danieli Giacomo,
Mondardini Maria Cristina,
Cordelli Duccio Maria,
Amigoni Angela,
Cesaroni Elisabetta,
Conio Alessandra,
Costa Paola,
Lombardini Martina,
Meleleo Rosanna,
Pugi Alessandra,
Tornaboni Elena Eve,
Santarone Marta Elena,
Vittorini Roberta,
Sartori Stefano,
Marini Carla,
Vigevano Federico,
Mastrangelo Massimo,
Pulitanò Silvia Maria,
Izzo Francesca,
Fusco Lucia
Publication year - 2022
Publication title -
epilepsia open
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.247
H-Index - 16
ISSN - 2470-9239
DOI - 10.1002/epi4.12627
Subject(s) - medicine , randomized controlled trial , ketamine , status epilepticus , refractory (planetary science) , clinical trial , protocol (science) , neuropsychology , anesthesia , pediatrics , surgery , epilepsy , psychiatry , alternative medicine , cognition , physics , astrobiology , pathology
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 ketamine and two of the five (40%) children in the control arm, where successfully treated with thiopental. In the remaining six (60%) enrolled patients, RCSE was not controlled by the randomized anesthetic(s). Significance The KETASER01 study was prematurely halted due to low eligibility of patients and no successful recruitment. No conclusions can be drawn regarding the objectives of the study. Here, we discuss the KETASER01 results and critically analyze the reasons for its failure in view of future trials.