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NCT06364540 · ClinicalTrials.gov registry record · Phase 4
Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED
A Phase 4 study of Pain, Acute, sponsored by Antonios Likourezos.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06364540 is a Phase 4 study of Pain, Acute that is actively recruiting participants, run by Antonios Likourezos. The registered enrollment target is 150 participants, above the 97-participant average among 31 other Pain, Acute trials with a reported enrollment target (55% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06364540, a Phase 4 study of Pain, Acute, is actively recruiting participants, sponsored by Antonios Likourezos.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled, patient-initiated delivery of analgesics in a measured and titratable fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings and for a lot of different reasons, such as to treat acute pain after surgery (like a sore throat after being intubated), as a pre-medication for general anesthesia, to treat cancer pain, and as a therapy for asthmaticus. Our research team has published two case series of 10 adult patients who were given nebulized ketamine (via BAN) for a variety of acute traumatic and non-traumatic painful conditions. The patients showed a 60% decrease in pain and a small number of side effects. Furthermore, our group published a randomized, double-blind trial of 120 adult patients evaluating the analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg), showing similar analgesic efficacy between the three different dosing regimens for short-term (up to 120 minutes) pain relief. Lastly, we recently completed a randomized, double-blind, double-dummy clinical trial comparing the analgesic efficacy and safety of nebulized ketamine and intravenous ketamine in managing acute pain in adult ED patients, with data currently being analyzed. Nebulized fentanyl given in the ED to adults with acute traumatic and non-traumatic pain syndromes at a dose range of 1.5-4 mcg/kg showed the same or even better pain-relieving effects than IV fentanyl and IV morphine alone. Our objective is to compare the analgesic efficacy and rates of side effects of a 0.75 mg/kg dose of ketamine administered via breath-actuated nebulizer (BAN) to a dose of 3 mcg/kg of fen
Conditions Studied
Interventions
- DRUG Ketamine
- DRUG Fentanyl
Study Locations (1)
New York
- Maimonides Medical Center - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06364540
The ClinicalTrials.gov registry entry for NCT06364540 describes a study currently listed as recruiting, 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, above the 97-participant average among 31 other Pain, Acute trials with a reported enrollment target (55% higher). The listed sponsor is Antonios Likourezos, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pain, Acute appearing as the primary indexed condition, and to 2 interventions - of which Ketamine is the first listed.
NCT06364540 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06364540 about?
NCT06364540 is a clinical study titled "Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED". In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled,...
What is the current status of trial NCT06364540?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2024-05-01. Estimated completion is 2026-12-31.
What conditions does trial NCT06364540 study?
This clinical trial studies the following conditions: Pain, Acute.
What interventions are being tested in trial NCT06364540?
The interventions under investigation include: Ketamine (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT06364540?
This trial is sponsored by Antonios Likourezos, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06364540 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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