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

NCT06110546 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-08-01

Study results available
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Summary

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

Conditions

  • Effect of Methadone on the Duration on Mechanical Ventilation

Interventions

DRUG

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).

DRUG

Usual care

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Pascal Kingah, MD,MPH · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-18
Primary Completion
2024-02-22
Completion
2024-02-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110546 on ClinicalTrials.gov