Dosing of Methadone for Spine Surgery

NCT03605901 ↗

Phase 2 Terminated 21 enrolled University of Florida

RandomizedParallel-groupSingle-blindSupportive care

Summary

This study compares two methods of dosing methadone for complex spine cases

Timeline

Start: 2019-03-19
Primary completion: 2025-05-09
Completion: 2025-05-09

Outcome

Missed primary endpoint

Stopped: “PI left institution.”

registry analysis (superiority test); Standard Dosing of Methadone vs Aliquots of Methadone Titrated to Apnea; p = 0.1449; Wilcoxon (Mann-Whitney) NCT03605901 ↗

registry analysis (superiority test); Standard Dosing of Methadone vs Aliquots of Methadone Titrated to Apnea; p = .5792; Wilcoxon (Mann-Whitney) NCT03605901 ↗

registry analysis (superiority test); Standard Dosing of Methadone vs Aliquots of Methadone Titrated to Apnea; p = .3497; Wilcoxon (Mann-Whitney) NCT03605901 ↗

Publications

Results Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methadone	Other / unclassified	0.2 mg/kg	—
Subject	Methadone	Other / unclassified	0.5 mg/kg	—