Journal Article 全身麻酔下における小児患者に対するレミフェンタニル塩酸塩の有効性及び安全性評価のための第Ⅲ相単群非盲検試験
A Phase III Multicenter, Open-Label, One-Arm Study to Evaluate the Efficacy and Safety of Remifentanil Hydrochloride for Pediatric Subjects under General Anesthesia

鈴木, 康之  ,  今中, 啓一郎  ,  伊豆本, 透  ,  柴田, さより  ,  名執, 真希子  ,  髙, 忠石

52 ( 2 )  , pp.33 - 41 , 2016-06-20 , 広島麻酔医学会
Remifentanil is a potent, selective, 4-anilidopiperidine µ- opioid receptor agonist not licensed for analgesia in the maintenance of general anesthesia in pediatric subjects in Japan. A phase III trial was conducted to evaluate remifentanil for pediatric subjects in Japan. This multicenter, open-label, one-arm study in pediatric subjects between 1 and 15 years of age receiving general anesthesia included 80 subjects. Nine subjects (11.3%) showed response to skin incision, which was the primary endpoint, and no apparent difference in response rate was found according to age (1–6, and 7–15 years old). Drug-related treatment emergent adverse events were found in 24 subjects (30.0%) with the most common event being heart rate decreased (26.3%). Remifentanil was found to be effective and safe for analgesia in maintenance of general anesthesia for pediatric subjects.

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