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Methadone for Spinal Fusion Surgery.

NCT04764825 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-11-25

No results posted yet for this study

Summary

A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing spinal fusion.

Conditions

  • Pain, Postoperative
  • Back Pain
  • Opioid Use
  • Methadone
  • Degenerative Spondylolisthesis
  • Stenosis, Spinal

Interventions

DRUG

Methadone

The dosage administered differ in regards to age and tolerance to opioids: 0.2 mg/kg: all patients \<65 years of age and all patients tolerant to opioids (defined as treatment with opioids (at least the last 7days) exceeding 60 oral morphine milligram equivalents daily. 0.15 mg/kg: Opioid naive patients \> 65 years of age.

DRUG

Morphine

The dosage administered differ in regards to age and tolerance to opioids: 0.2 mg/kg: all patients \<65 years of age and all patients tolerant to opioids (defined as treatment with opioids (at least the last 7days) exceeding 60 oral morphine milligram equivalents daily. 0.15 mg/kg: Opioid naive patients \> 65 years of age.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2024-03-19
Completion
2024-07-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT04764825 on ClinicalTrials.gov