Fentanyl versus hydromorphone for patients on mechanical ventilation
Fentanyl Versus Hydromorphone as First Line Strategy in Patients on Mechanical Ventilation, a Pilot Pragmatic Randomized Superiority Clinical Trial: the FenHydro Trial
This test compares fentanyl and hydromorphone to see which provides better pain control and sedation for adults on mechanical ventilation in the ICU.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07224620 on ClinicalTrials.gov |
What this trial studies
Adults admitted to select medical and family ICUs at Beth Israel Deaconess Medical Center who require mechanical ventilation and an opioid infusion for analgosedation are enrolled and assigned to receive either fentanyl or hydromorphone. The trial follows patients through their ICU stay to compare clinical outcomes such as duration of mechanical ventilation, ICU length of stay, and neurologic complications like delirium. The protocol leverages differences in pharmacology—onset, potency, metabolism, and metabolite accumulation—to monitor safety and efficacy. The aim is to provide prospective, patient-centered data to guide analgesic choice in critically ill ventilated patients.
Who should consider this trial
Good fit: Adults admitted to MICU A, B, C or the FICU at Beth Israel Deaconess who require mechanical ventilation and whose team plans an opioid infusion for analgosedation are ideal candidates.
Not a fit: Patients under 18, those with do-not-intubate or comfort-only orders, or those with contraindications to fentanyl or hydromorphone are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify which opioid leads to shorter ventilation times, fewer complications, and better recovery for ventilated ICU patients.
How similar studies have performed: Previous comparisons have been mostly small and retrospective with mixed results, so direct prospective head-to-head evidence between fentanyl and hydromorphone is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted to either MICU A, B, C or FICU at Beth Israel Deaconess Medical Center * Requiring mechanical ventilation * Felt by primary team to require opioid infusion for analgosedation Exclusion Criteria: * Age \< 18 years old * Do not intubate orders prior to enrollment * Comfort measures only * Contraindication to fentanyl or hydromorphone
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Elias N Baedorf-Kassis, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Valerie Goodspeed, MPH
- Email: vgoodspe@bidmc.harvard.edu
- Phone: 6176328055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.