科研之友
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摘要
Objective To investigate the safety, efficacy, and pharmacokinetic profile of dexmedetomidine in preterm and full-term neonates %26gt;= 28 to %26lt;= 44 weeks gestational age. %26lt;br%26gt;Study design Forty-two intubated, mechanically ventilated patients (n = 42) were grouped by gestational age into group I (n = 18), %26gt;= 28 to %26lt; 36 weeks, and group II (n = 24), %26gt;= 36 to %26lt;= 44 weeks. Within each age group, there were 3 escalating dose levels, including a loading dose (LD, mu g/kg) followed by a maintenance dose (MD, mu g.kg(-1).h(-1)) for 6-24 hours: level 1, 0.05 LD/MD; level 2, 0.1 LD/MD; and level 3, 0.2 LD/MD. The primary endpoint was the number of patients requiring sedation as determined by the Neonatal Pain, Agitation, Sedation Scale. %26lt;br%26gt;Results During dexmedetomidine infusion, 5% of Neonatal Pain, Agitation, Sedation Scale scores were %26gt; 3, indicating agitation/pain, with 4 patients (10%) requiring more sedation and 17 (40%) requiring more analgesia. Though there was significant variability in pharmacokinetic variables, group I appeared to have lower weight-adjusted plasma clearance (0.3 vs 0.9 L.h(-1).kg(-1)) and increased elimination half-life (7.6 vs 3.2 hours) compared with group II. Fifty-six adverse events (AEs) were reported in 26 patients (62%); only 3 AEs (5%) were related to dexmedetomidine. There were no serious AEs and no AEs or hemodynamic changes requiring dexmedetomidine discontinuation. %26lt;br%26gt;Conclusion Dexmedetomidine is effective for sedating preterm and full-term neonates and is well-tolerated without significant AEs. Preterm neonates had decreased plasma clearance and longer elimination half-life.
- 出版日期2014-2
