NCT02989597 — drugset

Summary

Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and demonstrates slow onset to withdrawal. The literature comparing methadone to more commonly used post-operative narcotics demonstrates that it manages pain better, sustains consistent plasma concentrations, decreases overall narcotic requirement, results in no additional adverse events, and is safe, even in children, across several studies. Since the standard of care is non-methadone narcotic usage to manage the significant pain of complex spinal surgery cases, it is understandable that methadone could be a desirable alternative to promote sustained pain control and early ambulation in these patients. The goal of this study is to compare the effect of a single dose of methadone administered intraoperatively in enrolled spinal fusion patients to their historical controls given fentanyl and morphine, and determine if more sustained pain control during the first few days after surgery provides a better subjective experience for the patient with less pain, which allows them to ambulate and leave the hospital sooner than patients given a standard regimen.

Timeline

Start: 2017-07-29
Primary completion: 2020-11-10
Completion: 2020-11-10

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methadone	Other / unclassified	0.2 mg/kg	Intravenous
Background	Dexamethasone	Small molecule	—	—
Background	Ketamine	Small molecule	4 ug/kg	—
Background	Remifentanil	Small molecule	0.1 ug/kg	—
Background	Sufentanil	Other / unclassified	0.3 ug/kg	—

Indications

No indication recorded.

Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients

Summary

Timeline

Publications

Drugs

Indications