Age-Specific Dose Regimens of Dexmedetomidine for Pediatric Patients in Intensive Care Following Elective Surgery: A Phase 3, Multicenter, Open-Label Clinical Trial in Japan.

ABSTRACT:

Objectives

To demonstrate the efficacy, safety, and pharmacokinetics of dexmedetomidine as a potential sedative for pediatric surgery patients in the ICU.

Design

Phase 3, multicenter, open-label study.

Setting

This study included 61 patients at 13 tertiary hospitals in Japan.

Patients

Pediatric patients (≥ 45 wk corrected gestational age to < 17 yr) undergoing intensive care treatment with mechanical ventilation requiring greater than 6 hours estimated duration of sedation following elective cardiac surgery.

Interventions

Dexmedetomidine was IV administered without a loading dose at age-specific dose regimens 0.2-1.4 (< 6 yr) and 0.2-1.0 µg/kg/hr (≥ 6 yr). The primary endpoint was the percentage of patients who did not require a rescue sedative (midazola

SUBMITTER: Takeuchi M 

PROVIDER: S-EPMC8565507 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature