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NCT04947085 · ClinicalTrials.gov registry record · Phase 4
Comparison of Nebulized Ketamine to Intravenous Sub-Dissociative Dose Ketamine for Pain
A Phase 4 study, sponsored by Antonios Likourezos.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT04947085 is a Phase 4 study that has completed, run by Antonios Likourezos. The registered enrollment target is 150 participants.
The verdict
NCT04947085, a Phase 4 study, has completed, sponsored by Antonios Likourezos.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study Summary
Ketamine is a non-competitive N-methyl-D-aspartate (NMDA)/glutamate receptor complex antagonist that decreases pain by diminishing central sensitization, hyperalgesia, and "wind-up" phenomenon at the level of the spinal cord (dorsal ganglion) and central nervous system (1). Ketamine administration in sub-dissociative doses (SDK) of 0.1-0.3 mg/kg in pre-hospital settings and in the ED results in effective pain relief in patients with acute traumatic and non-traumatic pain, chronic non-cancer and cancer pain, and in patients with opioid-tolerant pain by virtue of providing anti-hyperalgesia, anti-allodynia, and anti-tolerance (2-4). Two commonly utilized routes of SDK administration in the ED include an intravenous route (intravenous push dose or short infusion) and intranasal route. In the situation when intravenous access is not readily available or unobtainable, and intranasal route is not feasible, another non-invasive route of ketamine administration such as inhalation via Breath-Actuated Nebulizer (BAN) is coming into the play. The BAN allows a controlled patient-initiated delivery of analgesics in titratable fashion. Nebulized administration of ketamine has been studied in the areas of acute postoperative pain management (post-intubational sore throat), in anesthesia (pre-medication for general anesthesia,) and in managing cancer pain, and status asthmaticus therapy. However, our research team has published a case series of 5 patients receiving nebulized ketamine for a variety of acute painful conditions and has recently completed a randomized double-blind trial of 120 adult patients that evaluated analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED. Currently, we are conducting two additional studies evaluating the role of nebulized ketamine in pediatric ED and pre-hospital arena. In this study the investigators hypothesize that intravenous sub-dissociative-dose ketamine of 0.3 mg/kg will provide b
Interventions
- DRUG Ketamine via Intravenous
- DRUG Ketamine via BAN
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04947085
The ClinicalTrials.gov registry entry for NCT04947085 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Antonios Likourezos, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketamine via Intravenous is the first listed.
NCT04947085 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04947085 about?
NCT04947085 is a clinical study titled "Comparison of Nebulized Ketamine to Intravenous Sub-Dissociative Dose Ketamine for Pain". Ketamine is a non-competitive N-methyl-D-aspartate (NMDA)/glutamate receptor complex antagonist that decreases pain by diminishing central sensitization, hyperalgesia, and "wind-up" phenomenon at the level of the spinal cord (dorsal ganglion) and central nervous system (1). Ketamine administration i...
What is the current status of trial NCT04947085?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2021-10-04. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04947085?
The interventions under investigation include: Ketamine via Intravenous (DRUG), Ketamine via BAN (DRUG).
Who is sponsoring clinical trial NCT04947085?
This trial is sponsored by Antonios Likourezos, which has 33 total clinical trials registered on ClinicalTrials.gov.
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