Ketamine in Refractory Convulsive Status Epilepticus (KETASER01)

• ClinicalTrials.gov Identifier: NCT02431663
• Recruitment Status: Terminated
• First Posted: May 1, 2015
• Last Update Posted: October 8, 2020
• Sponsor: Meyer Children's Hospital
• Collaborators: Ospedali Riuniti Ancona; IRCCS Azienda Ospedaliero-Universitaria di Bologna; University of Padova; Bambino Gesù Hospital and Research Institute; Catholic University of the Sacred Heart; IRCCS Burlo Garofolo; Azienda Ospedaliera Universitaria Integrata Verona; Nuovo Regina Margherita Hospital; Vittore Buzzi Children's Hospital
• Information provided by (Responsible Party): Anna Rosati, Meyer Children's Hospital

Study Description

Brief Summary:

To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.

Condition or disease	Intervention/treatment	Phase
Status Epilepticus	Drug: Ketamine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
• Study Start Date: April 2015
• Actual Primary Completion Date: March 31, 2020
• Actual Study Completion Date: March 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: ketamine up to 100 mcg/kg/min; Two intravenous boluses of 2-3 mg/kg each of ketamine will be administered 5 minutes apart and immediately followed by a continuous infusion of 5-10 mcg/kg/min. Based on both clinical or electrographic responses, dosage will be increased every 10 minutes or longer, using 2 to 10 mcg/kg/ min increments, up to 60 mcg/kg/min. Maximum duration of infusion will be of 7 days.	Drug: Ketamine; Intravenous administration in continuous; Other Name: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)
Active Comparator: midazolam & thiopental & propofol; Midazolam intravenous will be increased every 5 minutes, using 2 mcg/kg/min increments, up to 12 mcg/kg/min and Thiopental intravenous will be increased every 30 minutes or longer, using 1 mg/kg/h increments, up to 6 mg/kg/h and Propofol intravenous will be increased every 5 minutes or longer, using 1 mg/kg/h increments, up to 5 mg/kg/h. Maximum duration of infusion for each drug will be 48 hours.	Drug: Ketamine; Intravenous administration in continuous; Other Name: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)

Outcome Measures

Primary Outcome Measures :

1. Number of participants with resolution of refractory convulsive status epilepticus [ Time Frame: participant wil be followed for 24 hours after discontinuation of study drug ]

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus
• Refractoriness of the drug I and II line
• Written informed consent from parents or legal guardian.
• Administration of rating scales in the risk of mortality (PIM III) and severity of SE (stess, status epilepticusseverity score) to be performed prior to randomization.

Exclusion Criteria:

• contraindications to the use of the medication/s in the study.
• pregnant or suspected pregnant.

Contacts and Locations

Locations

Italy

Anna Rosati

Firenze, Italy, 50139

Sponsors and Collaborators

Meyer Children's Hospital

Ospedali Riuniti Ancona

IRCCS Azienda Ospedaliero-Universitaria di Bologna

University of Padova

Bambino Gesù Hospital and Research Institute

Catholic University of the Sacred Heart

IRCCS Burlo Garofolo

Azienda Ospedaliera Universitaria Integrata Verona

Nuovo Regina Margherita Hospital

Vittore Buzzi Children's Hospital

Investigators

• Study Chair: Anna Rosati, MD, PhD; Children's Hospital A. Meyer of Firenze, Italy

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rosati A, De Masi S, Guerrini R. Ketamine for Refractory Status Epilepticus: A Systematic Review. CNS Drugs. 2018 Nov;32(11):997-1009. doi: 10.1007/s40263-018-0569-6.

Rosati A, Ilvento L, L'Erario M, De Masi S, Biggeri A, Fabbro G, Bianchi R, Stoppa F, Fusco L, Pulitanò S, Battaglia D, Pettenazzo A, Sartori S, Biban P, Fontana E, Cesaroni E, Mora D, Costa P, Meleleo R, Vittorini R, Conio A, Wolfler A, Mastrangelo M, Mondardini MC, Franzoni E, McGreevy KS, Di Simone L, Pugi A, Mirabile L, Vigevano F, Guerrini R. Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01). BMJ Open. 2016 Jun 15;6(6):e011565. doi: 10.1136/bmjopen-2016-011565.

• Responsible Party: Anna Rosati, MD, PhD, Meyer Children's Hospital
• ClinicalTrials.gov Identifier: NCT02431663
• Other Study ID Numbers: EudraCT number: 2013-004396-12
• First Posted: May 1, 2015
• Last Update Posted: October 8, 2020
• Last Verified: October 2020

Keywords provided by Anna Rosati, Meyer Children's Hospital:

refractory convulsive status epilepticus; ketamine; conventional anesthetics; children

Additional relevant MeSH terms:

Status Epilepticus; Seizures; Neurologic Manifestations; Nervous System Diseases; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action