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 type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv, Israel) |
| Status | Recruiting |
| Started | April 22, 2025 |
| Main results expected | April 22, 2028 |
| Study ends | April 22, 2028 |
| Registry record updated | May 13, 2025 |
| Trial ID | NCT06966869 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
- Study coordinator: Avner Leshem, MD-PhD
- Email: avnerle@tlvmc.gov.il
- Phone: +972-3-6973255
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.