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RECRUITING
NCT06966869

Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.

Sponsor: Tel-Aviv Sourasky Medical Center

View on ClinicalTrials.gov

Summary

This study investigates how well fentanyl is absorbed through the skin when delivered via a transdermal patch in critically ill surgical ICU patients. It compares hemodynamically stable patients with unstable patients who require vasopressors to maintain adequate blood pressure. Fentanyl blood levels will be measured over time to assess whether absorption is impaired in unstable patients. The goal is to determine whether transdermal fentanyl is a viable option for pain management in resource-limited ICUs or in situations where intravenous fentanyl is unavailable.

Official title: Pharmacokinetic Study Evaluating the Absorption of Fentanyl From Transdermal Patches in Hemodynamically Unstable Versus Stable Patients Admitted to the Surgical Intensive Care Unit.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-04-22

Completion Date

2028-04-22

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

DRUG

Transdermal fentanyl patch

The fentanyl patch will be applied as per standard ICU protocol for pain management. Blood levels will be monitored every 4 hours for 48 hours. Patients in this group require norepinephrine (\>5 drops/hour of 4 mg/50 mL) to maintain MAP ≥ 65 mmHg.

DRUG

Transdermal fentanyl patch

The fentanyl patch will be applied as per standard ICU protocol for pain management. Blood levels will be monitored every 4 hours for 48 hours. Patients in this group maintain MAP ≥ 65 mmHg without norepinephrine infusion.

Locations (1)

Tel Aviv Medical Center

Tel Aviv, Israel, Israel