Fentanyl vs Hydromorphone for Patients on Mechanical Ventilation

(FenHydro Trial)

Overseen By Eduardo MH Padrao, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Must be taking: Opioid infusion

Disqualifiers: Age < 18, Do not intubate, Comfort measures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two pain relief medications, fentanyl and hydromorphone, in ICU patients requiring mechanical ventilation. The goal is to determine which medication needs less overall dosing while still providing effective pain relief. Researchers focus on patients on breathing machines who need ongoing pain control. Suitable candidates for the trial are those currently using mechanical ventilation and requiring opioid pain management. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants the chance to contribute to important findings in pain management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both fentanyl and hydromorphone are generally safe for patients requiring mechanical ventilation. Research indicates that fentanyl is well-tolerated for calming and pain relief. It is often used with other medicines like midazolam, and this combination is considered safe and more effective for calming children on ventilators. No significant increase in serious side effects was found in adults either.

Studies comparing hydromorphone directly to fentanyl show no major differences in safety. Patients using either drug did not experience significantly different outcomes regarding the duration of mechanical ventilation. Some studies noted that starting hydromorphone in the ICU might be linked to a higher chance of long-term opioid use after hospital discharge, but this did not present a safety issue during the ICU stay itself.

Both drugs are standard choices in the ICU and have long-standing safety records. Each drug's side effects are well-known, and doctors typically choose based on the patient's specific needs and the drug's characteristics. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Fentanyl and Hydromorphone for patients on mechanical ventilation because these treatments offer potentially more effective and tailored options for managing pain and sedation in the ICU. Unlike other treatments, which might rely on a single opioid, this study explores using either Fentanyl or Hydromorphone as first-line agents. Fentanyl is known for its rapid onset and short duration, which can be beneficial for adjusting sedation levels quickly. Hydromorphone, on the other hand, may provide longer-lasting relief with potentially fewer side effects. By comparing these two, researchers aim to identify the optimal approach for analgosedation that maximizes patient comfort and safety.

What evidence suggests that this trial's treatments could be effective for patients on mechanical ventilation?

This trial will compare Fentanyl and Hydromorphone as first-line agents for analgosedation in ICU patients on mechanical ventilation. Research has shown that both Fentanyl and Hydromorphone effectively calm ICU patients on breathing machines. Studies have found that Fentanyl is often preferred over morphine for these patients because it is effective and can sometimes help them come off the ventilator sooner. Additionally, research indicates that Hydromorphone is as effective as Fentanyl for sedation, with no major differences in ventilator duration. Both drugs play a crucial role in managing pain and ensuring comfort for critically ill patients. ^{1 5 6 7 8}

Who Is on the Research Team?

Elias N Baedorf-Kassis, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with respiratory failure who are on mechanical ventilation in the ICU. It's designed to see if different pain medications affect patient outcomes. To join, individuals must meet certain health conditions that aren't specified here.

Inclusion Criteria

Admitted to either MICU A, B, C or FICU at Beth Israel Deaconess Medical Center

Requiring mechanical ventilation

My doctor thinks I need opioid infusion for pain and sedation.

Exclusion Criteria

Do not intubate orders prior to enrollment

I am under 18 years old.

I am receiving care focused on my comfort.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are randomized to receive either Fentanyl or Hydromorphone as first-line therapy for analgosedation in three-month blocks

6 months

Continuous monitoring during ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of primary and secondary outcomes

28 days

Daily assessments during ICU stay

Extension

Optional long-term follow-up to assess long-term outcomes and any delayed effects

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Fentanyl
• Hydromorphone

Trial Overview The FenHydro trial is testing whether Hydromorphone or fentanyl as analgesic agents can impact the amount of morphine milligram equivalents needed during mechanical ventilation. It's a head-to-head comparison in a randomized and pragmatic setting.

How Is the Trial Designed?

Group I: Hydromorphone as first line agent Experimental Treatment 1 Intervention

Patients in an ICU on a three-month period randomized to Hydromorphone will have Hydromorphone used as suggested first-line therapy for analgosedation, when clinically warranted.

Group II: Fentanyl as first line agent Experimental Treatment 1 Intervention

Patients in an ICU on a three-month period randomized to Fentanyl will have Fentanyl used as suggested first-line therapy for analgosedation, when clinically warranted.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9585711/

Effects of fentanyl administration in mechanically ventilated ... The present meta-analysis showed no significant difference in the duration of mechanical ventilation or the ICU stay between patients treated with fentanyl or ...

2. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202109-2112ED

American Journal of Respiratory and Critical Care Medicine The data from this trial provide a reasonable basis for using fentanyl infusions in preference to morphine in invasively mechanically ventilated adults in ICU.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1036731425000700

Opioid administration and weaning practices in ... Replacement of fentanyl infusion by enteral methadone decreases the weaning time from mechanical ventilation: a randomized controlled trial. Crit Care, 16 ...

4. journals.lww.com journals.lww.com/ccmjournal/fulltext/2020/01001/940__fentanyl_driven_analgosedation_versus.901.aspx

fentanyl-driven analgosedation versus traditional sedation ... The primary outcome was duration of mechanical ventilation. Secondary outcomes included medication exposure, adverse events and patient outcomes. Results ...

5. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/cc4939

Sedation in the intensive care unit with remifentanil/propofol ... A remifentanil-based regimen for analgesia and sedation supplemented with propofol significantly reduced the time on mechanical ventilation and allowed earlier ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1441277223022238

Remi-fent 1—A pragmatic randomised controlled study to ... The ICU mortality rate in the remifentanil arm was 27.6 % versus 24.3 % in the fentanyl arm; p = 0.60. Hospital mortality rate was 30.5 % in the remifentanil ...

7. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.1429

Efficacy and Safety of Analgosedation with Fentanyl ... Analgosedation with fentanyl appears to be a safe and effective strategy to facilitate mechanical ventilation. This regimen does not appear to ...

8. jkms.org jkms.org/DOIx.php?id=10.3346/jkms.2019.34.e21

Efficacy and safety of fentanyl in combination with ... Fentanyl combined with midazolam is safe and more effective than midazolam alone for sedation therapy in mechanically ventilated children.