Fentanyl rotation from subcutaneous to transdermal administration: A validation of current practice - FARAO

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•- Age >=18 years;
•- Able to understand the written information and able to give informed consent.
•- Current treatment with subcutaneous fentanyl and planned to rotate to
•transdermal fentanyl
•- To ensure steady-state kinetics, patients must have been treated with
•subcutaneous fentanyl for at least 40 hours prior to the rotation and have been
•treated with a stable fentanyl dose at least 20 hours prior to the rotation
•This way, fentanyl pharmacokinetics are at steady-state.

•- Patients that use short-acting fentanyl via the oral, (oral mucosal,
•sublingual), intranasal or subcutaneous administration route 12 hours prior to
•the rotation will be excluded as this influences the pharmacokinetic profile of
•the subcutaneous administration. This implicates that patients will be
•prescribed oral short acting oxycodone or morphine 12 hours before rotation as
•these are mostly used next to treatment with transdermal fentanyl.
•- Patients that use strong CYP3A4 inhibitors or inducers, as spacified by the
•KNMP kennisbank, will be excluded as the model did not account for the
•influence of strong CYP3A4 inhibition or induction on fentanyl pharmacokinetics
•while the effects have been shown in multiple studies.
•- Patients that are rotated using a dose conversion ratio other than 1:1 will
•also be excluded.

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