Fentanyl versus morphine for sedation and pain control in adults on mechanical ventilation
Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
This trial will test whether fentanyl or morphine, given with propofol, helps reach target sedation levels faster and reduces the need for extra sedative doses in adults on mechanical ventilation in the ICU.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 1 site (Kota Bharu, Kelantan) |
| Trial ID | NCT06479655 on ClinicalTrials.gov |
What this trial studies
Adults in the ICU who need invasive mechanical ventilation and continuous infusion sedation within 12 hours of admission are randomized to receive either fentanyl or morphine together with propofol. The proportion of patients reaching the target sedation score at 12 and 24 hours and the proportion requiring rescue sedation doses are recorded. Duration of mechanical ventilation, length of ICU stay, and 14-day mortality are also compared between the two groups. Patients with chronic opioid use, severe liver or end-stage renal failure, pregnancy, neuromuscular blockade, severe neurocognitive dysfunction, drug overdose, known allergy to the drugs, or severe traumatic brain injury are excluded.
Who should consider this trial
Good fit: Adults over 18 admitted to the ICU who are expected to need invasive mechanical ventilation for more than 24 hours and who will start continuous infusion sedation within 12 hours of admission are ideal candidates.
Not a fit: Patients with chronic opioid use, severe liver or end-stage renal failure, pregnancy, neuromuscular blockade, severe neurocognitive impairment, drug overdose, known allergy to fentanyl or morphine, or severe traumatic brain injury are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If one drug provides more reliable sedation with fewer rescue doses, it could shorten time on the ventilator and reduce ICU length of stay.
How similar studies have performed: Both fentanyl and morphine are commonly used for ICU sedation and prior studies have produced mixed results, with some suggesting more predictable sedation with fentanyl but no clear mortality advantage for either agent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years old * Patients who are expected by the ICU team to require invasive mechanical ventilation in ICU for at least more than 24 hours and for whom the ICU team decides to initiate continuous infusion of sedation * A patient who was ventilated and sedated not more than 12 hours before ICU admission. Exclusion Criteria: * Patients with chronic use of narcotics * Patients with chronic liver failure or end-stage renal failure * Patients with severe chronic neurocognitive dysfunction * Patients with drug overdose * Patients with a known allergy to either morphine or fentanyl * Patients who are receiving neuromuscular blockers * Patients who are pregnant * Patients who are diagnosed to have severe traumatic brain in
Where this trial is running
Kota Bharu, Kelantan
- Hospital Universiti Sains Malaysia — Kota Bharu, Kelantan, Malaysia (Recruiting)
Study contacts
- Study coordinator: Mohd Zulfakar Mazlan Dr, MBBS
- Email: zulfakar@usm.my
- Phone: +60135335566
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.