Retrospective analysis of the analgosedative efficacy and safety of midazolam combined with fentanyl in mechanically ventilated neonates.

Purpose: To compare the analgosedative efficacy and safety of the combination of midazolam and fentanyl with those of midazolam monotherapy in mechanically ventilated neonates.

Materials and methods: We conducted a single-center retrospective analysis of mechanically ventilated patients in our neonatal intensive care unit from April 1, 2021 to December 1, 2024. After dividing patients into midazolam + fentanyl (M + F) and midazolam (M) groups according to their respective sedation/analgesia regimens, we conducted intergroup comparisons of pain scores, ventilator parameters, and vital signs 5 min pre-treatment and at post-treatment time points (1 h, 3 h, 12 h, 24 h, 48 h). We also compared pre-and post-treatment (3 h, 24 h, 48 h) non-invasive hemodynamic parameters; adverse reactions; and discharge outcomes of the two groups.

Results: A total of 210 neonates were included, with 106 in the M + F group and 104 in the M group. N-PASS pain scores obtained 5 min pre-treatment were similar between the two groups (P > 0.05); however, N-PASS scores were significantly lower in the M + F than in the M group at each post-treatment time point (1 h, 3 h, 12 h, 24 h, 48 h) (all P < 0.05). Ventilator parameters (MAP, FIO₂) obtained 5 min pre-treatment were similar (P > 0.05), but were significantly lower at each post-treatment time point (1 h, 3 h, 12 h, 24 h, 48 h) in the M + F group (all P < 0.05). Pre- and post-treatment (1 h, 3 h, 12 h, 24 h, 48 h) vital signs did not differ between the two groups (P > 0.05). Pre-and post-treatment (3 h, 24 h, 48 h) non-invasive hemodynamic parameters were similar between the two groups (P > 0.05). There were no significant intergroup differences in adverse reactions or discharge outcomes (P > 0. 05).

Conclusion: The combination of midazolam and fentanyl relieved pain and reduced ventilator parameters more effectively than midazolam monotherapy, without increasing adverse reactions or worsening discharge outcomes among mechanically ventilated neonates.