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.
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Fentanyl
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Freque
Sponsors
National Center for Child Health and Development
Research Institute, Osaka Medical Center and Research Institute for Maternal and Child Health Kitasato University Hospital Kobe University Hospital National Center for Child Health and Development The University of Tokyo Hospital National Hospital Organization Okayama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation based on % increase of systolic blood pressure, and heart rate within 20min after first invasive surgical procedure. | — |
Countries
Japan
Contacts
Public ContactKuriyama Takeshi
National Center for Child Health and Development
Outcome results
None listed