Remifentanil versus morphine-midazolam premedication on the quality of endotracheal intubation in neonates: a noninferiority randomized trial.

ABSTRACT

OBJECTIVE: To compare remifentanil and morphine-midazolam for use in nonurgent endotracheal intubation in neonates. STUDY DESIGN: In this prospective noninferiority randomized trial, newborns of gestational age ≥28 weeks admitted in the neonatal intensive care unit requiring an elective or semielective endotracheal intubation were divided into 2 groups. One group (n = 36) received remifentanil (1 µg/kg), and the other group (n = 35) received morphine (100 µg/kg) and midazolam (50 µg/kg) at a predefined time before intubation (different in each group), to optimize the peak effect of each drug. Both groups also received atropine (20 µg/kg). The primary outcome was to compare the conditions of intubation, and the secondary outcome was to compare the duration of successful intubation, physiological variables, and pain scores between groups for first and second intubation attempts. Adverse events and neurologic test data were reported. RESULTS: Intubation with remifentanil was not inferior to that with morphine-midazolam. At the first attempted intubation, intubation conditions were poor in 25% of the remifentanil group and in 28.6% of the morphine-midazolam group (P = .471). For the second attempt, conditions were poor in 28.6% of the remifentanil group, compared with 10% of the morphine-midazolam group (P = .360). The median time to successful intubation was 33 seconds (IQR, 24-45 seconds) for the remifentanil group versus 36 seconds (IQR, 25-59 seconds) for the morphine-medazolam group (P = .359) at the first attempt and 45 seconds (IQR, 35-64 seconds) versus 56 seconds (IQR, 44-68 seconds), respectively, for the second attempt (P = .302). No significant between-group difference was reported for hypotension, bradycardia, or adverse events. CONCLUSION: In our cohort, remifentanil was at least as effective as the morphine-midazolam regimen for endotracheal intubation. Thus, premedication using this very-short-acting opioid can be considered in urgent intubations and is advantageous in rapid extubation.