Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-18

Study Completion Date

2024-02-22

Brief Summary

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The purpose of this study is to determine the effect of methadone on the duration on mechanical ventilation in critically ill patients receiving more than 72 hours of mechanical ventilation (MV) by comparing the number of ventilator free days from enrollment to the time of discharge, to assess the safety of methadone administration in critically ill patients while in the hospital and to determine hospital length of stay from the time of enrollment to the time of discharge

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Detailed Description

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Conditions

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Effect of Methadone on the Duration on Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Methadone group

Group Type EXPERIMENTAL

Methadone group

Intervention Type DRUG

Participants will be started on Methadone 5mg, 10mg or 15mg every 8 hours depending on Fentanyl drip rate (0-100mcg/hr, 100-200mcg/hr or \>200mcg/hr) or hydromorphone drip rate (0-1.5mg/hr, 1.5-3mg/hr, or \>3mg/hr).

Non-Methadone group

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type DRUG

Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols

Interventions

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Methadone group

Participants will be started on Methadone 5mg, 10mg or 15mg every 8 hours depending on Fentanyl drip rate (0-100mcg/hr, 100-200mcg/hr or \>200mcg/hr) or hydromorphone drip rate (0-1.5mg/hr, 1.5-3mg/hr, or \>3mg/hr).

Intervention Type DRUG

Usual care

Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients on Intermittent mandatory ventilation (IMV) for more than 72 hours
* Patients infused Fentanyl or Hydromorphone for more than 72 hours
* Patients with evidence of reversal of process that caused respiratory failure, adequate oxygenation (PaO2/fraction of inspired oxygen (FiO2)\>200; Positive end expiratory pressure (PEEP)≤8 and Ph≥7.2
* Patients hemodynamically stable
* Patients with a failed single or multiple attempts at spontaneous breathing trials

Exclusion Criteria

* Patients with history of opioid drug abuse
* Patients receiving schedule II narcotics on a chronic basis for longer than 6 months prior to ICU admission or on other analgesic infusions other than Fentanyl or Hydromorphone
* Patients with cervical spinal cord injury or neuromuscular disease
* Patients with end stage liver disease at ICU admission (ie, International normalized ratio ≥2and not taking warfarin and/or a total serum bilirubin ≥1.5 times above normal limits
* Patients with prolonged QTc interval ≥500
* Patients with prior history of cardiac conduction defects or sudden death
* Patients with QTc increase of ≥60 milliseconds above the value of prior EKGs measured during current ICU admission
* Patients with more than 5 days on IV analgesia
* Patients intubated for more than 3 days
* Patients without feeding tubes
* Patients not receiving enteral feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No