At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 129 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 0.12 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Double Blinded Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
In Brief
A Phase 2 clinical trial evaluating Ketamine and Saline for Spinal Fusion. Completed, enrolled 129 participants across 1 site.
Detailed Summary
The aim of the proposed study is to examine the effectiveness of low dose postoperative ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid naïve patients after major spine surgery. Primary endpoints of the study are to determine the effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain and opioid requirements.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Fusion
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
Primary CompletionNov 2014
Study CompletionSep 2017
First PostedSep 2017
TodayJul 2026
First PostedSep 7, 2017
Enrollment StartNov 1, 2012
Primary CompletionNov 1, 2014
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 8.8 years ago
Interventions
Ketaminedrug
0.12 mg/kg/hr of ketamine post surgery
Salinedrug
Saline will be administered at the same rate as the ketamine infusion.