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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sedana Medical
• Treatments: Isoflurane; Midazolam

Criteria

Inclusion Criteria:

• Patients at least 3 years to 17 (less than 18) years at the time of randomization, admitted to an ICU/with planned ICU admission.

• Expected mechanical (invasive) ventilation and sedation for at least 12 hours.

• Informed consent obtained from the patient, patient's legal guardian(s)

Exclusion Criteria:

• Ongoing seizures requiring acute treatment.

• Continuous sedation for more than 72 hours at time of randomization.

• Less than 24 hours post cardiopulmonary resuscitation.

• Uncompensated circulatory shock.

• Known or suspected genetic susceptibility to malignant hyperthermia.

• Patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion.

• Patient with tidal volume below 30 mL or above 800 mL.

• Inability to perform reliable COMFORT-B assessment in the opinion of the Investigator

• Patients with intracranial pressure (ICP) monitoring or with suspected increase in ICP

• Patients with treatment-induced whole-body hypothermia.

• Patients with pheochromocytoma.

• Patients with prolonged QT interval or with significant risk for prolonged QT interval.

• Patient not expected to survive next 48 hours or not committed to full medical care.