Actively Recruiting

Age: 18Years - 70Years
All Genders
NCT06966869

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

Led by Tel-Aviv Sourasky Medical Center · Updated on 2025-05-13

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-70 years
  • Male or female patients
  • Admitted to the surgical intensive care unit (ICU)
  • Indications for pain management using fentanyl
Not Eligible

You will not qualify if you...

  • No clinical indication for fentanyl analgesia (e.g., pain well controlled with non-opioid medications)
  • Known allergy or hypersensitivity to fentanyl
  • Contraindications to fentanyl (e.g., severe constipation, hepatic failure)
  • Patients infected with multidrug-resistant organisms requiring high-level isolation (biosafety level 2 or higher)
  • Hemodynamically very unstable patients requiring >20 drops/hour of norepinephrine (4 mg/50 mL), with or without vasopressin support

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tel Aviv Medical Center

Tel Aviv, Israel, Israel

Actively Recruiting

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Research Team

A

Avner Leshem, MD-PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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