jRCT1091220006已完成不适用
evaluation of safety, dosage and efficacy of fentanyl in neonates and children of age 6 years old and younger -uncontrolled, open label study- (IISPedAne001)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 主要终点
- systolic blood pressure
研究概览
简要总结
暂无简介。
入排标准
- 年龄范围
- 0age over 至 6age old under（—）
入选标准
- •Patients who require administration of narcotic analgesia during surgery/procedures. Patients must be hospitalized, intubated, vetilated and receiving general anesthesia.
- •6 years old or younger.
- •Written informed consent from legal representative.
排除标准
- •outpatients
- •patients who receive epidural anesthetics.
- •patients who have been intubated before surgery.
- •patients who received nalcotic analgesia before surgery.
- •patients with unstable circulatory status because of congenital cardiac anomaly, diaphragmatic hernia, and so on.
- •patients with severely impaired hepatic or renal function.
- •patients who have history of serious drug allergy.
- •Patients who have taken or is taking ritonavir.
结局指标
主要结局
systolic blood pressure
时间窗: 20 min after first invasive surgical procedure
% increase of systolic blood pressure within 20 min after first invasive surgical procedure
heart rate
时间窗: 20 min after first invasive surgical procedure
% increase of heart rate within 20 min after first invasive surgical procedure
次要结局
- % increase of systolic blood pressure(within 20min after first invasive surgical procedure)
- heart rate(within 20min after first invasive surgical procedure)
研究者
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evaluation of safety, dosage and efficacy of fentanyl in neonates and children of age 6 years old and younger -uncontrolled, open label studyPatients who require administration of narcotic analgesia during general anesthesia for operation or procedures. Patients must be intubated, under respiratory care and receiving general anesthesia. Patients who is receiving epidural anesthetics must be excluded.JPRN-jRCT1091220006ational Center for Child Health and Development120
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