Clinical trial Recruiting at 1 site Observational Ages 18 to 70

Evaluating how well fentanyl patches work in unstable ICU patients

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.

Run by Tel-Aviv Sourasky Medical Center · NCT06966869 · Data updated 2026-11-12

This study tests how well fentanyl patches work for pain relief in critically ill ICU patients who are either unstable and need extra support or stable and don’t.

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment40 (estimated)
SponsorTel-Aviv Sourasky Medical Center
Government
Locations1 site (Tel Aviv, Israel)
StatusRecruiting
StartedApril 22, 2025
Main results expectedApril 22, 2028
Study endsApril 22, 2028
Registry record updatedMay 13, 2025
Trial IDNCT06966869 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-70 admitted to the surgical ICU with a need for pain management using fentanyl.

Probably not a fit

Patients with well-controlled pain using non-opioid medications or those with severe hemodynamic instability requiring high doses of norepinephrine will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the absorption of fentanyl delivered via transdermal patches in critically ill surgical ICU patients. It compares two groups: hemodynamically unstable patients requiring vasopressors and stable patients not needing such support. Blood levels of fentanyl will be measured over time to assess absorption differences between the groups. The study aims to determine the viability of transdermal fentanyl for pain management in resource-limited settings or when intravenous options are unavailable.

Why it matters

Potential benefit: If successful, this study could provide a new pain management option for critically ill patients who are hemodynamically unstable.

How similar studies have gone: While the approach of using transdermal fentanyl in ICU settings is not widely tested, similar studies have shown promise in other patient populations.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Tel Aviv Medical Center
    Tel Aviv, Israel, Israel
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.