RecruitingNot Applicable

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

Israel40 participantsStarted 2025-04-22

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18-70 years. * Male or female patients. * Admitted to the surgical intensive care unit (ICU). * Indications for pain management using fentanyl. Exclusion Criteria: * 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 require 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in fentanyl absorption (AUC) between stable and unstable ICU patients

Timeframe: From patch application to 48 hours post-application

Trial details

NCT IDNCT06966869

SponsorTel-Aviv Sourasky Medical Center

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2028-04-22

Contact for this trial

Avner Leshem, MD-PhD

+972-3-6973255 avnerle@tlvmc.gov.il

View on ClinicalTrials.gov More Pain Management trials