Transdermal fentanyl patch: The fentanyl patch will be applied as per standard ICU protocol for pain management. Blood levels will be monitored every 4 hours for 48 hours. Patients in this group require norepinephrine (\>5 drops/hour of 4 mg/50 mL) to maintain MAP ≥ 65 mmHg.
Transdermal fentanyl patch: The fentanyl patch will be applied as per standard ICU protocol for pain management. Blood levels will be monitored every 4 hours for 48 hours. Patients in this group maintain MAP ≥ 65 mmHg without norepinephrine infusion.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Difference in fentanyl absorption (AUC) between stable and unstable ICU patients — From patch application to 48 hours post-application Comparison of the area under the fentanyl concentration-time curve (AUC) between hemodynamically unstable and stable ICU patients receiving a transdermal fentanyl patch. Blood samples will be taken every 4 hours over a 48-hour period following patch application.
Trial sites (1)
Facility
City
Region
Status
Tel Aviv Medical Center
Tel Aviv
Israel
Recruiting
More Tel-Aviv Sourasky Medical Center trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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