A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion

Completed · Phase 2 · Has a placebo group

Conditions studied: Spinal Fusion

In brief

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.

Key facts

Study ID

NCT03274453

Run by

NYU Langone Health

People needed

129

Starts

2012-11-01

Expected to finish

2017-09-01

Last updated by the study team

2018-06-14

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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