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Effect of substitution of intravenous infusion of fentanyl by enteral methadone on the time of weaning from mechanical ventilation in critically ill patients in intensive care units for adults

Replacement of fentanyl infusion by enteral methadone decreases the weaning time from mechanical ventilation: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85308779
Enrollment
75
Registered
2011-06-29
Start date
2005-04-29
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical ventilation in critically ill adult patients Respiratory Mechanical ventilation in critically ill patients

Interventions

The enrolled patients were randomized into two groups: the methadone group (MG), for whom intravenous fentanyl was replaced with enteral methadone
and the control group (CG), who underwent a gradual reduction of intravenous fentanyl. 1. The MG received the following treatment: 1.1. One capsule of methadone (10 mg) was administered enterally eve

Sponsors

Sao Jose Municipal Hospital (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The subjects studied were severely ill patients who required MV and the continuous use of fentanyl and who met the following inclusion criteria: 1.1. MV for at least five days 1.2. The use of fentanyl analgesia in varying doses for at least five day or 1.3. A dose of fentanyl more than or equal to 5 µg/kg/h for at least 12 days. 2. Subjects were also required to meet the following ventilation weaning criteria: 2.1. Reversal of the process that caused the respiratory failure 2.2. Adequate oxygenation (PaO2/FiO2) > 200 2.3. Positive end-expiratory pressure (PEEP) less than or equal to 5; FiO2 less than or equal to 0.4 and pH more than or equal to 7.25 2.4. Hemodynamic stability (with minimal or no vasoactive drugs) and neurological stability (ability to initiate respiratory effort)

Exclusion criteria

Exclusion criteria: 1. Patients younger than 18 years 2. Patients with terminal diseases 2. Patients with cervical spinal cord injuries or neuromuscular diseases

Design outcomes

Primary

MeasureTime frame
Duration of ventilation weaning (weaning success was defined as 48 hrs without reinstitution of mechanical ventilation)

Secondary

MeasureTime frame
1. Duration of mechanical ventilation 2. Length of ICU stay 3. Length of hospital stay

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026