Evaluating how well fentanyl patches work in 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.
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tel-Aviv Sourasky Medical Center Government |
| Locations | 1 site (Tel Aviv, Israel) |
| Trial ID | NCT06966869 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 admitted to the surgical ICU with a need for pain management using fentanyl.
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.
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 performed: While the approach of using transdermal fentanyl in ICU settings is not widely tested, similar studies have shown promise in other patient populations.
Eligibility criteria
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 this trial is running
Tel Aviv, Israel
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.