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

Sedana Medical

Status and phase: Completed; Phase 3

Conditions: Sedation

Treatments: Drug: Midazolam; Drug: Isoflurane

Study type: Interventional

Funder types: Industry

Identifiers

NCT04684238

SED002

Details and patient eligibility

About

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

Full description

This is a phase III, multi-centre, prospective, randomized, active-controlled, assessor-blind study. Primary endpoint: percentage of time of adequately maintained sedation, in absence of rescue sedation, within the COMFORT-B interval (light, moderate, or deep sedation) prescribed at randomization, monitored every 2 hours for an expected minimum of 12 hours (up to 48 hours).

Enrollment: 94 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Drug: Midazolam

Active Comparator group

Description:

Midazolam for sedation in the ICU

Treatment:

Drug: Midazolam

Drug: Isoflurane

Experimental group

Description:

Volatile for sedation in the ICU

Treatment:

Drug: Isoflurane