臨床研究等提出・公開システム

evaluation of safety, dosage and efficacy of fentanyl in neonates and children of age 6 years old and younger -uncontrolled, open label study- (IISPedAne001)

evaluation of safety, dosage and efficacy of fentanyl in neonates and children of age 6 years old and younger -uncontrolled, open label study-

Hidefumi Nakamura, M.D.,Ph.D. Director

National Center for Child Health and Development

2-10-1 Okura Setagaya-ku Tokyo , 157-8535 JAPAN

Kuriyama Takeshi

National Center for Child Health and Development

2-10-1 Okura Setagaya-ku Tokyo , 157-8535 JAPAN

+81-3-5494-7120

kuriyama-t@ncchd.go.jp

COMPLETED

Feb. 01, 2005

Interventional

Single-arm study

open(masking not used)

No

3

1) Patients who require administration of narcotic analgesia during surgery/procedures. Patients must be hospitalized, intubated, vetilated and receiving general anesthesia.
2) 6 years old or younger.
3) Written informed consent from legal representative.

1) outpatients
2) patients who receive epidural anesthetics.
3) patients who have been intubated before surgery.
4) patients who received nalcotic analgesia before surgery.
5) patients with unstable circulatory status because of congenital cardiac anomaly, diaphragmatic hernia, and so on.
6) patients with severely impaired hepatic or renal function.
7) patients who have history of serious drug allergy.
8) Patients who have taken or is taking ritonavir.

Both

Patients 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.

Intervention type:DRUG Name of intervention:Fentanyl Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:

Efficacy evaluated by physicians' clinical observation. % increase of systolic blood pressure and heart rate within 20 min after first invasive surgical procedure should be considered for physicians' decision-making.

Evaluation based on % increase of systolic blood pressure, and heart rate within 20min after first invasive surgical procedure.