Status:
RECRUITING
Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Pain Management
Critical Illness
Eligibility:
All Genders
18-70 years
Brief 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 ...
Detailed Description
This is a single-center, pharmacokinetic study evaluating fentanyl absorption from transdermal patches in critically ill patients admitted to the surgical intensive care unit (ICU). A total of 40 pati...
Eligibility Criteria
Inclusion
- Adults aged 18-70 years.
- Male or female patients.
- Admitted to the surgical intensive care unit (ICU).
- Indications for pain management using fentanyl.
Exclusion
- 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.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 22 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06966869
Start Date
April 22 2025
End Date
April 22 2028
Last Update
May 13 2025
Active Locations (1)
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1
Tel Aviv Medical Center
Tel Aviv, Israel, Israel