Pain ManagementNCT06966869
Evaluation of Fentanyl Transdermal Patch Absorption in Hemodynamically Unstable ICU Patients.
An observational study of Pain Management and Critical Illness, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain Management, Critical Illness
- What is being tested?
- Transdermal fentanyl patch
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Apr 2025to 22 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted to a surgical intensive care unit.
Who may be able to join
- Adults aged 18-70 years.
- Male or female patients.
- Admitted to the surgical intensive care unit (ICU).
- Indications for pain management using fentanyl.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pharmacokinetic Study Evaluating the Absorption of Fentanyl From Transdermal Patches in Hemodynamically Unstable Versus Stable Patients Admitted to the Surgical Intensive Care Unit.
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.
Read the 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 patients will be recruited and divided into two groups. Both groups will receive a transdermal fentanyl patch for pain management. The grouping is based on hemodynamic status: 20 patients will be classified as hemodynamically unstable, defined by the need for intravenous norepinephrine infusion (≥5 drops/hour of a 4 mg/50 mL solution) to maintain a mean arterial pressure (MAP) of at least 65 mmHg. The other 20 patients will be considered hemodynamically stable, maintaining a MAP ≥ 65 mmHg without norepinephrine infusion. Patients who require very high doses of norepinephrine (over 20 drops/hour), with or without vasopressin, will be excluded.
The objective is to determine whether hemodynamic instability affects the systemic absorption of fentanyl from transdermal patches. Blood levels of fentanyl will be measured every 4 hours for the first 48 hours following patch application. The area under the concentration-time curve (AUC) will be calculated for each participant. The primary outcome is the difference in AUC between the stable and unstable groups.
Secondary variables include clinical and physiological factors that may influence fentanyl absorption, such as age, sex, body mass index (BMI, as a proxy for adiposity), body temperature, and liver function.
To ensure appropriate pain control in all participants, supplemental analgesia (non-fentanyl-based) will be administered during the first 24 hours after patch application and again at 48-72 hours, as needed. The ICU nursing team will routinely assess pain using validated tools such as the Behavioral Pain Scale (BPS), in accordance with standard unit practice.
- Conditions
- Pain Management, Critical Illness
- Being tested
- Transdermal fentanyl patch
- Keywords
- Transdermal fentanyl, Critical illness, Hemodynamic instability
- Medical subject headings
- Agnosia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal fentanyl patchDrug
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.
Transdermal fentanyl patchDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamically stable ICU patients receiving transdermal fentanyl without norepinephrine | Not described Receives: Drug: Transdermal fentanyl patch | |
| Hemodynamically unstable ICU patients receiving transdermal fentanyl and intravenous norepinephrine | Not described Receives: Drug: Transdermal fentanyl patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From patch application to 48 hours post-application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start22 Apr 2025
- Primary completion22 Apr 2028 (estimated)
- Study completion22 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966869
- Sponsor's protocol ID
- TLV-0344-24
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study Evaluating the Absorption of Fentanyl From Transdermal Patches in Hemodynamically Unstable Versus Stable Patients Admitted to the Surgical Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT06966869
- Acronym / sponsor ID
- TLV-0344-24
- Conditions
- Pain Management, Critical Illness
- Keywords
- Transdermal fentanyl, Critical illness, Hemodynamic instability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 22 Apr 2028 (estimated)
- Study completion
- 22 Apr 2028 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patients will be recruited and divided into two groups. Both groups will receive a transdermal fentanyl patch for pain management. The grouping is based on hemodynamic status: 20 patients will be classified as hemodynamically unstable, defined by the need for intravenous norepinephrine infusion (≥5 drops/hour of a 4 mg/50 mL solution) to maintain a mean arterial pressure (MAP) of at least 65 mmHg. The other 20 patients will be considered hemodynamically stable, maintaining a MAP ≥ 65 mmHg without norepinephrine infusion. Patients who require very high doses of norepinephrine (over 20 drops/hour), with or without vasopressin, will be excluded.
The objective is to determine whether hemodynamic instability affects the systemic absorption of fentanyl from transdermal patches. Blood levels of fentanyl will be measured every 4 hours for the first 48 hours following patch application. The area under the concentration-time curve (AUC) will be calculated for each participant. The primary outcome is the difference in AUC between the stable and unstable groups.
Secondary variables include clinical and physiological factors that may influence fentanyl absorption, such as age, sex, body mass index (BMI, as a proxy for adiposity), body temperature, and liver function.
To ensure appropriate pain control in all participants, supplemental analgesia (non-fentanyl-based) will be administered during the first 24 hours after patch application and again at 48-72 hours, as needed. The ICU nursing team will routinely assess pain using validated tools such as the Behavioral Pain Scale (BPS), in accordance with standard unit practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to a surgical intensive care unit.
Key inclusion criteria (4 listed)
- Adults aged 18-70 years.
- Male or female patients.
- Admitted to the surgical intensive care unit (ICU).
- Indications for pain management using fentanyl.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal fentanyl patchThe 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. | Drug | Hemodynamically unstable ICU patients receiving transdermal fentanyl and intravenous norepinephrine |
| Transdermal fentanyl patchThe 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. | Drug | Hemodynamically stable ICU patients receiving transdermal fentanyl without norepinephrine |
Primary outcome
Difference in fentanyl absorption (AUC) between stable and unstable ICU patients
Time frame: From patch application to 48 hours post-application
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management and Critical Illness, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avner Leshem, MD-PhD (+972-3-6973255, avnerle@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in fentanyl absorption (AUC) between stable and unstable ICU patients (time frame: From patch application to 48 hours post-application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.