Delirium in the Intensive Care UnitNCT05697783
Methadone vs. Transdermal Fentanyl for Opioid Withdrawal Syndrome
An observational study of Delirium in the Intensive Care Unit, run by Meir Medical Center at 1 site in Israel.
Trial summary
Many patients in the general intensive care unit experience pain, as a result of an injury or underlying disease, surgery or an invasive procedure. Pain management is an integral part of the treatment of critical patients, and this is first and foremost to alleviate their suffering. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Delirium in the Intensive Care Unit
- What is being tested?
- Administration of methadone instead of fentanyl patch
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged 18-99 who were treated with methadone in the intensive care unit from November 2021 to November 2022, as well as all patients aged 18-99 who were admitted to the intensive care unit from November 2020 to November 2021 and were treated with a fentanyl patch as a control group.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methadone vs. Transdermal Fentanyl for Opioid Withdrawal Syndrome : Comparison of Two Groups of Intubated and Ventilated Patients in the Intensive Care Unit: Before-after Intervention Study
Many patients in the general intensive care unit experience pain, as a result of an injury or underlying disease, surgery or an invasive procedure.
Pain management is an integral part of the treatment of critical patients, and this is first and foremost to alleviate their suffering. Along with this, there is another therapeutic benefit in the form of relief from symptoms accompanying pain such as an increase in oxygen consumption, immune changes, hyper metabolism etc.
Read more
Currently, the pain treatment is based on a multi-modal analgesia approach in which drugs from several drug groups and different mechanisms are given, in order to relieve the pain by suppressing several nerve and inflammatory pathways. However, the treatment is still based on opioids, despite multiple adverse effects, including tolerance and withdrawal syndrome.
Opioids affect several receptors, mainly the µ receptor, in an agonistic, antagonistic or agonistic-antagonistic manner. The main opioids used for pain relief in the intensive care unit are morphine, fentanyl and remifentanil.
After prolonged treatment with opioids, a sudden cessation of their use will result in a withdrawal syndrome which will manifest itself in delirium, restlessness, hypertension, anxiety, sweating, vomiting etc. (2-3). In order to avoid the withdrawal syndrome, the dose must be tapered down gradually, often using alternative long-term opioids, such as methadone and buprenorphine (-4).
In the general intensive care unit at our institution, patients were treated with fentanyl patches in decreasing doses in order to lead the patient safely through the withdrawal syndrome, while trying to reduce the negative physiological effects as much as possible. In November 2021, we started using oral methadone instead of fentanyl patches, as a long acting opioid, as used in many ICU's worldwide, in order to avoid withdrawal syndrome in patients who received continuous infusion of short-acting opioids, such as remifentanil, for long periods of time while being intubated and ventilated. In the past year since the methadone treatment was started, 50 patients were treated in the unit with methadone with the indication of relieving the withdrawal symptoms from opioids.
We intent to investigate whether there is a difference in the incidence of delirium in patients who were treated with methadone vs patients who were treated with fentanyl patches in order to alleviate withdrawal symptoms.
- Conditions
- Delirium in the Intensive Care Unit
- Being tested
- Administration of methadone instead of fentanyl patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of methadone instead of fentanyl patchDrug
Also called comparison of delirium rates in methadone vs fentanyl patch treated patients
comparison of delirium rates in methadone vs fentanyl patch treated patients
| Study group | Role | What they receive |
|---|---|---|
| Methadone-treated group | Not described Receives: Drug: Administration of methadone instead of fentanyl patch | |
| Fentanyl-patch treated group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
Delirium as estimated by RASS score
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Dec 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in the Intensive Care UnitStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697783
- Sponsor's protocol ID
- 0008-23-MMC
- Status last verified
- Mar 2024
- First submitted
- 4 Jan 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone vs. Transdermal Fentanyl for Opioid Withdrawal Syndrome : Comparison of Two Groups of Intubated and Ventilated Patients in the Intensive Care Unit: Before-after Intervention Study
- ClinicalTrials.gov ID
- NCT05697783
- Acronym / sponsor ID
- 0008-23-MMC
- Conditions
- Delirium in the Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 26 Jan 2023 (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.
Many patients in the general intensive care unit experience pain, as a result of an injury or underlying disease, surgery or an invasive procedure.
Pain management is an integral part of the treatment of critical patients, and this is first and foremost to alleviate their suffering. Along with this, there is another therapeutic benefit in the form of relief from symptoms accompanying pain such as an increase in oxygen consumption, immune changes, hyper metabolism etc.
Currently, the pain treatment is based on a multi-modal analgesia approach in which drugs from several drug groups and different mechanisms are given, in order to relieve the pain by suppressing several nerve and inflammatory pathways. However, the treatment is still based on opioids, despite multiple adverse effects, including tolerance and withdrawal syndrome.
Opioids affect several receptors, mainly the µ receptor, in an agonistic, antagonistic or agonistic-antagonistic manner. The main opioids used for pain relief in the intensive care unit are morphine, fentanyl and remifentanil.
After prolonged treatment with opioids, a sudden cessation of their use will result in a withdrawal syndrome which will manifest itself in delirium, restlessness, hypertension, anxiety, sweating, vomiting etc. (2-3). In order to avoid the withdrawal syndrome, the dose must be tapered down gradually, often using alternative long-term opioids, such as methadone and buprenorphine (-4).
In the general intensive care unit at our institution, patients were treated with fentanyl patches in decreasing doses in order to lead the patient safely through the withdrawal syndrome, while trying to reduce the negative physiological effects as much as possible. In November 2021, we started using oral methadone instead of fentanyl patches, as a long acting opioid, as used in many ICU's worldwide, in order to avoid withdrawal syndrome in patients who received continuous infusion of short-acting opioids, such as remifentanil, for long periods of time while being intubated and ventilated. In the past year since the methadone treatment was started, 50 patients were treated in the unit with methadone with the indication of relieving the withdrawal symptoms from opioids.
We intent to investigate whether there is a difference in the incidence of delirium in patients who were treated with methadone vs patients who were treated with fentanyl patches in order to alleviate withdrawal symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone-treated group | – | Drug: Administration of methadone instead of fentanyl patch |
| Fentanyl-patch treated group | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18-99 who were treated with methadone in the intensive care unit from November 2021 to November 2022, as well as all patients aged 18-99 who were admitted to the intensive care unit from November 2020 to November 2021 and were treated with a fentanyl patch as a control group.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Administration of methadone instead of fentanyl patchAlso: comparison of delirium rates in methadone vs fentanyl patch treated patientscomparison of delirium rates in methadone vs fentanyl patch treated patients | Drug | Methadone-treated group |
Primary outcome
Delirium
Time frame: through study completion, an average of 2 years
Delirium as estimated by RASS score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Delirium in the Intensive Care Unit, run by Meir 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 15 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: through study completion, an average of 2 years). 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 15 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.