NCT06966869 Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.
| NCT ID | NCT06966869 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tel-Aviv Sourasky Medical Center |
| Condition | Pain Management |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2028-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-04-22 with a primary completion date of 2028-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06966869 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Pain Management. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06966869 currently recruiting?
Yes, NCT06966869 is actively recruiting participants. Contact the research team at avnerle@tlvmc.gov.il for enrollment information.
Where is the NCT06966869 trial being conducted?
This trial is being conducted at Tel Aviv, Israel.
Who is sponsoring the NCT06966869 clinical trial?
NCT06966869 is sponsored by Tel-Aviv Sourasky Medical Center. The trial plans to enroll 40 participants.