Sedana Medical AB (publ) announced that the main results from the paediatric IsoCOMFORT study have been published in the Clinical Trials Registry EudraCT. IsoCOMFORT was a randomised active-controlled assessor-blinded study comparing the efficacy and safety of sedation with inhaled isoflurane, administered via the company's medical device Sedaconda ACD-S, with intravenous midazolam in mechanically ventilated paediatric patients 3 to 17 years old. The primary endpoint was to compare the time that the targeted sedation depth was maintained.

Key secondary endpoints included opioid requirements during sedation, time to extubation and adverse events. As previously communicated, the primary endpoint, proportion of time at target sedation level, was met in the main analysis (full analysis data set) with least square means (LSM) (95% confidence interval[CI]) of 68.94 (52.83 to 85.05)% for isoflurane vs 62.37 (44.70 to 80.04)% for midazolam, but not in the per protocol analysis set (LSM [95% CI] of 70.91 [50.75 to 91.07]% for isoflurane vs 65.57 [44.03 to 87.11]% for midazolam). Opioid requirements were significantly lower during sedation with isoflurane than with midazolam, with LSM [95% CI] of 2.1 [1.3 to 2.9] fentanyl equivalents/hour for isoflurane vs.

4.6 [3.5 to 5.6] for midazolam. There was no indication of tolerance development during the treatment period. Time to extubation after end of treatment was significantly shorter in the isoflurane group with median (interquartile range) time to extubation of 0.75 (0.25 to 1.5) hours for the isoflurane group vs 1.09 (0.49 to 5.50) hours for the midazolam group.

There was no statistical difference in the proportion of time with spontaneous breathing. Adverse events were reported for more isoflurane-treated patients than midazolam-treated patients (83,6% vs 63,6%). The majority of the adverse events were unrelated to treatment and mild and those related to treatment were in line with the known safety profile of isoflurane.