drugset / Trial / NCT05913284

Intravenous Methadone in Perioperative Acute and Chronic Management in Chinese Adult Cardiac Surgical Patients

NCT05913284

Phase 3 Active not recruiting 86 enrolled Chinese University of Hong Kong
RandomizedParallel-groupDouble-blindTreatment

Summary

Despite modern day improvements in pain treatment and availability of different analgesic modalities, suboptimal postoperative pain control remains an issue in cardiac surgical patients. Poorly controlled acute postoperative pain is associated with adverse physiological outcomes that impair the recovery of cardiac surgical patients. It is associated with decreased patient satisfaction, delayed postoperative ambulation, and the development of chronic postsurgical pain (CPSP). Intravenous opioids such as fentanyl and morphine have been the mainstay of perioperative analgesia for cardiac surgery, either by intermittent boluses by healthcare staff or through a patient-controlled device (PCA). The primary problem with this mechanism of delivery is that significant fluctuations in serum opioid concentrations can occur, resulting in effects which range from inadequate analgesia to overdose and respiratory depression. In contrast to intermittent administration of short-acting opioids such as morphine and fentanyl, a single dose administration of methadone can be considered.

Timeline

Start
2024-01-15
Primary completion
2026-02-01
Completion
2026-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Methadone Other / unclassified 0.2 mg/kg Intravenous
Comparator Morphine Other / unclassified Intravenous