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Methadone versus fentanil and oxycodone for post-operative pain reduction in patients undergoing coronary artery bypass grafting and/or valve surgery – a placebo-controlled, double-blind, randomized clinical trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519224-24-00
Acronym
4000
Enrollment
220
Registered
2025-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-10

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

Conditions

Following heart surgery, patients experience poor postoperative pain control and a moderate/high opioid consumptions. This is correlated to adverese events and poor outcome.

Brief summary

The primary endpoint will be cumulated intravenous morphineequivalent consumption within 48 hours from surgery

Detailed description

Intraoperative need for inotropes and vasopressors, Pain intensity assessed by the Numeric Rating Scale (NRS) at rest and at cough., Pain intensity assessed by the Numeric Rating Scale (NRS) during physiotherapeutic testing, Time from arrival in CICU until patient extubating and mobilization., CICU Length of stay (time from arrival at CICU until booking of transfer to the ward), Days until bowel function (movement, Flatus, stool), Quality of Recovery 1516 at postoperative day 0, 1, 2, 3, 30 and 90., Quality of life assessed by the SF-3617 after 90 days., Chronic pain assessment at 30 and 90 days after surgery., Time to hospital discharge., 3 months mortality, Reported occurrence of postoperative arrythmias

Interventions

DRUGFentanyl "B. Braun" 50 mikrogram/ml injektionsvätska
DRUGlösning
DRUGMETHADONE
DRUGLindoxa
DRUGopløsning
DRUGinjektionsvæske

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be cumulated intravenous morphineequivalent consumption within 48 hours from surgery

Secondary

MeasureTime frame
Intraoperative need for inotropes and vasopressors, Pain intensity assessed by the Numeric Rating Scale (NRS) at rest and at cough., Pain intensity assessed by the Numeric Rating Scale (NRS) during physiotherapeutic testing, Time from arrival in CICU until patient extubating and mobilization., CICU Length of stay (time from arrival at CICU until booking of transfer to the ward), Days until bowel function (movement, Flatus, stool), Quality of Recovery 1516 at postoperative day 0, 1, 2, 3, 30 and 90., Quality of life assessed by the SF-3617 after 90 days., Chronic pain assessment at 30 and 90 days after surgery., Time to hospital discharge., 3 months mortality, Reported occurrence of postoperative arrythmias

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026