PACULit Daily Literature Update: Inhaled isoflurane for sedation of mechanically ventilated children in intensive care (IsoCOMFORT): a multicentre, randomised, active-control, assessor-masked, non-inferiority phase 3 trial

Miatello J, Palacios-Cuesta A, Radell P, et al. Inhaled isoflurane for sedation of mechanically ventilated children in intensive care (IsoCOMFORT): a multicentre, randomised, active-control, assessor-masked, non-inferiority phase 3 trial. Lancet Respir Med. 2025 Jul;:-. doi: S2213-2600(25)00203-6. | PMID: 40680761

This multicentre, randomised, active-control, assessor-masked, non-inferiority phase 3 trial evaluated the safety and efficacy of inhaled isoflurane compared to standard intravenous sedation in mechanically ventilated children admitted to intensive care units.

Key Learning Points

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  Inhaled isoflurane sedation was non-inferior to standard intravenous sedation for sedation effectiveness in ventilated pediatric patients.
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  The inhaled sedation was well tolerated without significant adverse events and facilitated rapid awakening.