Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07224620

Fentanyl Versus Hydromorphone in Patients on Mechanical Ventilation

Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-20

300

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with respiratory failure who require mechanical ventilation are not only at risk of death, but also of complications of prolonged ICU stay. Patients may have significant functional decline, impact in quality of life, develop psychiatric disorders and at long-term can lead to significant cost to society. Although sedation and analgesia are considered only supportive therapy, several studies have shown that in patients on mechanical ventilation, different approaches can have significant impact on patient centered outcomes. However, to date, randomized clinical trials on critically ill patients have mostly evaluated the sedative agent but not the analgesic agent. Although morphine and its derivates are the most common used opioid analgesic agents in the critical care setting, only some retrospective studies and some prospective studies compared them head-to-head (ramifentanyl versus morphine and fentanyl versus morphine). Current guidelines recommend choosing the analgesic agent based on pharmacokinectics, physician experience and side-effects profile. To evaluate the differences of two standard-of-care analgosedation agents, the FenHydro trial will be a cluster randomized, pragmatic, pilot and feasibility superiority clinical trial in mechanically ventilated patients in the ICU. The main question the study hopes to answer is whether there is any difference in morphine milligram equivalents administered during mechanical ventilation.

CONDITIONS

Official Title

Fentanyl Versus Hydromorphone in Patients on Mechanical Ventilation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to either MICU A, B, C or FICU at Beth Israel Deaconess Medical Center
  • Requiring mechanical ventilation
  • Primary team determines opioid infusion for sedation and analgesia is needed
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Do not intubate orders before enrollment
  • Receiving comfort measures only
  • Known contraindications to fentanyl or hydromorphone

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

V

Valerie Goodspeed, MPH

CONTACT

E

Eduardo MH Padrao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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