RecruitingNCT06966869

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

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

Sponsor

Tel-Aviv Sourasky Medical Center

Enrollment

40 participants

Start Date

Apr 22, 2025

Study Type

OBSERVATIONAL

Conditions

Pain Management Critical Illness

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Transdermal fentanyl patch and a drug called Transdermal fentanyl patch for people with critical illness and pain management. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTransdermal 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.

DRUGTransdermal 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.