CompletedPhase 2ketamine
A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
Sponsored by NYU Langone Health
NCT ID
NCT03274453
Target Enrollment
129 participants
Start Date
2012-11-01
Est. Completion
2017-09
About This Study
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.
Conditions Studied
Interventions
- •Ketamine
- •Saline
Eligibility
Age:16 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Adult and teenage (\>/=16) male or female who will undergo surgery for multilevel (\>4 level) spinal fusion from a posterior approach with general anesthesia, and who are fluent English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable. * If female, subject is non-lactating and is either: * Not of childbearing potential * Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing. * Subject is ASA physical status 1, 2, or 3. Exclusion Criteria: * anxiety * psychiatric disorder * Allergy or sensitivity to ketamine or dilaudid * Deemed un-acceptable by study team * Cognitively impaired (by history) * Subject requires chronic antipsychotic medication * Subject known to be in liver failure * Subject for whom opioids or ketamine are contraindicated * Patients with narrow angle glaucoma * Patients with a history of psychosis
Study Locations (1)
New York University School of Medicine
New York, New York, United States