Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorTel-Aviv Sourasky Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-70 years.
Male or female patients.
Admitted to the surgical intensive care unit (ICU).
Indications for pain management using fentanyl.
Disqualifiers
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).
Trial population
Critically ill patients admitted to a surgical intensive care unit.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Transdermal fentanyl patch
DrugThe 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
DrugThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Hemodynamically stable ICU patients receiving transdermal fentanyl without norepinephrine1 intervention
Group B: Hemodynamically unstable ICU patients receiving transdermal fentanyl and intravenous norepinephrine1 intervention
Trial outcomes
Primary outcomes
1
Difference in fentanyl absorption (AUC) between stable and unstable ICU patients
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.
Time frame
From patch application to 48 hours post-applicationSponsors and contacts
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Source ClinicalTrials.gov