NCT02431663

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

5 years

First QC Date

April 3, 2015

Last Update Submit

October 5, 2020

Conditions

Status Epilepticus

Keywords

refractory convulsive status epilepticusketamineconventional anestheticschildren

Outcome Measures

Primary Outcomes (1)

  • Number of participants with resolution of refractory convulsive status epilepticus

    participant wil be followed for 24 hours after discontinuation of study drug

Study Arms (2)

ketamine up to 100 mcg/kg/min

EXPERIMENTAL

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

midazolam & thiopental & propofol

ACTIVE COMPARATOR

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

Interventions

KetamineDRUG

Intravenous administration in continuous

Also known as: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)
ketamine up to 100 mcg/kg/minmidazolam & thiopental & propofol

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anna Rosati

Florence, 50139, Italy

Location

Related Publications (2)

  • 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.

    PMID: 30232735DERIVED

  • Rosati A, Ilvento L, L'Erario M, De Masi S, Biggeri A, Fabbro G, Bianchi R, Stoppa F, Fusco L, Pulitano 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.

    PMID: 27311915DERIVED

MeSH Terms

Conditions

Status Epilepticus

Interventions

Ketamine

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Anna Rosati, MD, PhD

    Children's Hospital A. Meyer of Firenze, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 3, 2015

First Posted

May 1, 2015

Study Start

April 1, 2015

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

IT(1)