A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
Postoperative pain is severe after major spine surgery. Opioids such as morphine and
hydromorphone are routinely used for postoperative pain control. These drugs have significant
side effects, most importantly respiratory depression, nausea, constipation and tolerance.
Moreover, many spine surgery patients have used opioid pain medication for back pain long
term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led
to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated
side effects and tolerance.
Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses.
Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA
receptors are involved in central pain sensitization via wind-up phenomenon and altered pain
memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the
development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to
decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of
administration.
Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life
of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory
depression.
Phase:
Phase 4
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health