NCT06364540 Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED
| NCT ID | NCT06364540 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Antonios Likourezos |
| Condition | Pain, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2024-05-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 fentanyl administered via breath-actuated nebulizer (BAN) in adult patients presenting to the ED with acute painful conditions.
Eligibility Criteria
Inclusion Criteria: * age 18+ years * acute painful condition * pain score of 5 or more on a standard 11 point numeric rating scale (NRD) * patient needs to be awake, alert, and oriented as to person, place, and time * demonstrated understanding of the informed consent process and content * patient needs to demonstrate the ability to verbalize the nature of any adverse effects (AE) * patient needs to experience as well as express their pain severity by using the NRS Exclusion Criteria: * patient with a painful condition warranting emergent/urgent intervention in the ED * patients with altered mental status * allergy to ketamine or fentanyl * pregnant or breastfeeding * weight greater than 100 kg * patients presenting with head injury * unstable vital signs (systolic blood pressure \<90 mmHg or \>180 mmHg, pulse rate \<50 beats/min or \>150 beats/min, and respiration rate \<10 breaths/min or \>30 breaths/min) * inability to provide consent * current medical history of alcohol or drug abuse * administration of opioids or opioid antagonist/agonist within 4-6 hours prior to arrival and NSAIDs 6 hours prior to arrival to the t
Contact & Investigator
Sergey Motov, MD
PRINCIPAL INVESTIGATOR
Maimonides Medical Center
Frequently Asked Questions
Who can join the NCT06364540 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Pain, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06364540 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06364540 currently recruiting?
Yes, NCT06364540 is actively recruiting participants. Contact the research team at alikourezos@maimo.org for enrollment information.
Where is the NCT06364540 trial being conducted?
This trial is being conducted at Brooklyn, United States.
Who is sponsoring the NCT06364540 clinical trial?
NCT06364540 is sponsored by Antonios Likourezos. The principal investigator is Sergey Motov, MD at Maimonides Medical Center. The trial plans to enroll 150 participants.