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NCT02424591 · ClinicalTrials.gov registry record · Phase 4
A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT02424591 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 46 participants.
The verdict
NCT02424591, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02424591
The ClinicalTrials.gov registry entry for NCT02424591 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02424591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02424591 about?
NCT02424591 is a clinical study titled "A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion". 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 p...
What is the current status of trial NCT02424591?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2014-08. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02424591?
The interventions under investigation include: Placebo (OTHER), Ketamine (DRUG).
Who is sponsoring clinical trial NCT02424591?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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