Paediatric anaesthesia & critical care
Inhaled isoflurane for sedation of mechanically ventilated children in intensive care (IsoCOMFORT): a multicentre, randomised, active-control, assessor-masked, non-inferiority phase 3 trial
Authors' conclusion
Among critically ill children, the effectiveness of sedation with inhaled isoflurane was non-inferior to that of intravenous midazolam, offering an alternative medication in children receiving mechanical ventilation.
Study context
- Population
- Critically ill children aged 3–17 years requiring invasive mechanical ventilation and sedation for an expected ≥12 h, 19 PICUs in Spain, France, Germany and UK92 in full analysis set
- Participants
- 96 children
- Comparison
- Inhaled isoflurane vs IV midazolam sedation
- Isofluranen = 63
- Midazolamn = 33reference
- Primary endpoint
- Percentage of time with adequate sedation depth within the individually prescribed COMFORT-B target range, without rescue sedation, monitored every 2 h
- Follow-up
- Minimum of 12 h (up to 48±6 h)
Methodological detailsmulticentre, active-control, assessor-masked, non-inferiority, phase 3, 2:1 randomisation, Sedation titrated to a prescribed COMFORT Behaviour (COMFORT-B) target range; treatment planned for up to 48 h (±6 h)
- Multicentre
- Active-control
- Assessor-masked
- Non-inferiority
- Phase 3
- 2:1 randomisation
- Sedation titrated to a prescribed COMFORT-B target range; treatment planned for up to 48 h (±6 h)
Primary result
As reported in the abstract
Percentage of time in COMFORT-B target range
Further findings
- No treatment-related deaths
Safety
Serious adverse events (safety set, n=94)
Denominator Isoflurane 61 · Midazolam 33
Events
| Outcome | Isoflurane | Midazolam |
|---|---|---|
| Treatment-related severe hypotension | 1 | 1 |
| Discontinuation due to adverse events | 3 | — not stated in the abstract |
— not stated in the abstract
Serious adverse events (safety set, n=94)
- None considered related to study treatment
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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. Published 15 July 2025. doi:10.
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