Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically 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.
Tel-Aviv Sourasky Medical Center
40 participants
Apr 22, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- Adults aged 18-70 years.
- Male or female patients.
- Admitted to the surgical intensive care unit (ICU).
- Indications for pain management using fentanyl.
Exclusion Criteria5
- 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.
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Interventions
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.
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.
Locations(1)
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NCT06966869