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. 2022 Sep;7(3):532-540.
doi: 10.1002/epi4.12627. Epub 2022 Jul 25.

KETASER01 protocol: What went right and what went wrong

Anna Rosati  1 , Manuela L'Erario  2 , Roberto Bianchi  3 , Sara Olivotto  4 , Domenica Immacolata Battaglia  5 , Francesca Darra  6 , Paolo Biban  7 , Annibale Biggeri  8 , Dolores Catelan  8 , Giacomo Danieli  9 , Maria Cristina Mondardini  10 , Duccio Maria Cordelli  11 , Angela Amigoni  12 , Elisabetta Cesaroni  13 , Alessandra Conio  14 , Paola Costa  15 , Martina Lombardini  1 , Rosanna Meleleo  16 , Alessandra Pugi  17   18 , Elena Eve Tornaboni  17   18 , Marta Elena Santarone  19 , Roberta Vittorini  20 , Stefano Sartori  21 , Carla Marini  13 , Federico Vigevano  19 , Massimo Mastrangelo  4 , Silvia Maria Pulitanò  22 , Francesca Izzo  23 , Lucia Fusco  19
Affiliations

KETASER01 protocol: What went right and what went wrong

Anna Rosati et al. Epilepsia Open. 2022 Sep.

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 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.

Keywords: children; non-profit study; refractory status epilepticus; treatment.

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Conflict of interest statement

None of the authors has any conflicts of interest to disclose.

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