The Pharmacokinetics of Fentanyl in Intensive Care Patients

• Status: Unknown status
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is part of a project intended to develop guidelines to optimise the dosing of fentanyl in intensive care patients.

This study will focus on determining:

• Whether the pharmacokinetics of fentanyl change during the ICU stay.

• To what extent / the degree of change in fentanyl pharmacokinetics in ICU patients.

• Which factors (e.g. physiological variables) that cause such a change.

• Based on simulations, determine context-sensitive half-times of fentanyl in ICU patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Collaborator: University of California
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• Consecutive patients admitted to the ICU at Oslo University Hospital - Ullevål, in whom mechanical ventilation for > 72 hrs. is expected

• Aged 18 - 80 years, both inclusive

• Serum beta-HCG negative if female of childbearing potential, aged 18 - 45 years (both inclusive)

Exclusion Criteria:

• Tracheally intubated > 12 hrs. before admittance to the ICU

• Known hypersensitivity to fentanyl or other opioids

• Post partum < 6 weeks and/or lactating

• Informed consent not received

• Any reason why, in the opinion of the investigator and/or the treating physicians, the patient should not participate in the study