Efficacy and Safety of Fentanyl in Combination with Midazolam in Children on Mechanical Ventilation

Bongjin Lee, June Dong Park, Yu Hyeon Choi, Young Joo Han, Dong In Suh, Bongjin Lee, June Dong Park, Yu Hyeon Choi, Young Joo Han, Dong In Suh

Abstract

Background: To evaluate the efficacy and safety of fentanyl for sedation therapy in mechanically ventilated children.

Methods: This was a double-blind, randomized controlled trial of mechanically ventilated patients between 2 months and 18 years of age. Patients were randomly divided into two groups; the control group with midazolam alone, and the combination group with both fentanyl and midazolam. The sedation level was evaluated using the Comfort Behavior Scale (CBS), and the infusion rates were adjusted according to the difference between the measured and the target CBS score.

Results: Forty-four patients were recruited and randomly allocated, with 22 patients in both groups. The time ratio of cumulative hours with a difference in CBS score (measured CBS-target CBS) of ≥ 4 points (i.e., under-sedation) was lower in the combination group (median, 0.06; interquartile range [IQR], 0-0.2) than in the control group (median, 0.15; IQR, 0.04-0.29) (P < 0.001). The time ratio of cumulative hours with a difference in CBS score of ≥ 8 points (serious under-sedation) was also lower in the combination group (P < 0.001). The cumulative amount of midazolam used in the control group (0.11 mg/kg/hr; 0.07-0.14 mg/kg/hr) was greater than in the combination group (0.07 mg/kg/hr; 0.06-0.11 mg/kg/hr) (P < 0.001). Two cases of hypotension in each group were detected but coma and ileus, the major known adverse reactions to fentanyl, did not occur.

Conclusion: Fentanyl combined with midazolam is safe and more effective than midazolam alone for sedation therapy in mechanically ventilated children.

Trial registration: ClinicalTrials.gov Identifier: NCT02172014.

Keywords: Children; Fentanyl; Mechanical Ventilation; Midazolam; Sedation.

Conflict of interest statement

Disclosure: The authors have no potential conflicts of interest to disclose.

Figures

Fig. 1. Flow of participants. Of the…
Fig. 1. Flow of participants. Of the 2,065 patients admitted to the PICU during the study period, 44 patients were enrolled and randomly assigned, with 22 patients in either the control group or combination group.
PICU = pediatric intensive care unit, CNS = central nervous system.
Fig. 2. Differences between measured CBS score…
Fig. 2. Differences between measured CBS score and target CBS score. The differences in the target and measured CBS scores (CBS difference) were calculated for the patients throughout the study period for the control group (blue) and combination group (red).
CBS = Comfort Behavior Scale.

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