Period | Screening | Study period | ||||||
---|---|---|---|---|---|---|---|---|
Study day | −30 to −1 | −1 | 0 | 1 | 2 | 3–5 | 6 | Discharge |
Informed consent | X | |||||||
Medical history | X | |||||||
Demographic data | X | |||||||
Physical examination | X | X | ||||||
Vital signs | X | X | X | X | X | X | X | Xd |
Injection site evaluation | Xb | Xb | Xb | Xb | Xb | Xb | Xb,d | |
Laboratory tests | X | Xa | X | |||||
12-lead ECG/chest x-ray | X | |||||||
Inclusion/exclusion criteria | X | |||||||
Randomization | X | |||||||
Naldebain® administration | Xb | |||||||
Surgery | X | |||||||
Pain assessment | X | X | X | X | X | X | ||
BPI | X | X | X | |||||
Patient satisfaction | X | |||||||
Concomitant medication | X | X | X | X | X | X | X | Xd |
Adverse event record | X | X | X | X | X | X | Xd | |
Drug accountability for fentanyl | Xe | Xe | Xe | |||||
Discharge | Xc | |||||||
End of study | X |