Status:
COMPLETED
A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
Lead Sponsor:
NYU Langone Health
Conditions:
Spinal Fusion
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 ma...
Detailed Description
Subjects aged 16 to 75, ASA I to III, scheduled for an elective lumbar fusion surgery of at least two levels under general anaesthesia, were prospectively studied. We defined opioid-tolerant as the da...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT03274453
Start Date
November 1 2012
End Date
September 1 2017
Last Update
June 14 2018
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016