Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.

NCT06966869 | Recruiting FDA Drug

• 1 other identifier: TLV-0344-24
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Critical Illness

Keywords

Transdermal fentanyl; Critical illness; Hemodynamic instability

Outcome Measures

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.

  From patch application to 48 hours post-application

Study Arms (2)

Hemodynamically stable ICU patients receiving transdermal fentanyl without norepinephrine

Drug: Transdermal fentanyl patch

Hemodynamically unstable ICU patients receiving transdermal fentanyl and intravenous norepinephrine

Drug: Transdermal fentanyl patch

Interventions

Transdermal fentanyl patch DRUG

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.

Hemodynamically unstable ICU patients receiving transdermal fentanyl and intravenous norepinephrine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients admitted to a surgical intensive care unit.

You may qualify if:

• Adults aged 18-70 years.
• Male or female patients.
• Admitted to the surgical intensive care unit (ICU).
• Indications for pain management using fentanyl.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Agnosia; Critical Illness

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Central Study Contacts

Avner Leshem, MD-PhD

CONTACT

+972-3-6973255; avnerle@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): April 22, 2028
• Study Completion (Estimated): April 22, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

IL (1)