NCT03605901

Dosing of Methadone for Spine Surgery

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Standard dosing of methadone	Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
DRUG	Aliquots of methadone titrated to apnea	Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals.

Timeline

• Start date: 2019-03-19
• Primary completion: 2025-05-09
• Completion: 2025-05-09
• First posted: 2018-07-30
• Last updated: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study