Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old

PHASE3CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

January 14, 2021

Primary Completion Date

January 19, 2023

Study Completion Date

January 19, 2023

Conditions
Sedation
Interventions
DRUG

Midazolam

Solution for Injection/Infusion

DRUG

Isoflurane

Inhalation vapour, liquid. Isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device)

Trial Locations (24)

Unknown

Hôpital Femme-Mère-Enfant Groupe Hospitalier Est, Lyon

CHU de NANTES, Hôpital Mère-Enfant, Nantes

Hôpital Robert-Debré AP-HP, Paris

Hôpitaux Universitaires Paris Sud Site Bicetre, Paris

Centre Hospitalier Universitaire de Reims, Reims

Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre, Strasbourg

Universitätsklinikum Köln, Cologne

Universitätsklinik Freiburg, Freiburg im Breisgau

Universitätsklinikum Hamburg-Eppendorf (UKE), Hamburg

Universitätsklinikum Jena, Jena

Hospital Materno Infantil Sant Joan de Deu Hospital, Barcelona

Hospital Universitario Reina Sofía, Córdoba

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Infantil Universitario Niño Jesús Pediatric Intensive Care Unit, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

Hospital Regional Universitario, Carlos Haya, Málaga

Hospital Universitario Virgen del Rocio de Sevilla, Seville

Hospital Universitari i Politecnic La Fe, Valencia

Karolinska Universitetssjukhus Solna, Solna

Leeds Teaching Hospitals NHS Trust, Leeds

University Hospitals of Leicester NHS Trust, Leicester

Imperial College Healthcare NHS Trust, London

Royal Manchester Children's Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sedana Medical

INDUSTRY