Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED

Recruiting now · Phase 4

Conditions studied: Pain, Acute

In brief

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.

Key facts

Study ID: NCT06364540
Run by: Antonios Likourezos
People needed: 150
Starts: 2024-05-01
Expected to finish: 2026-12-31
Last updated by the study team: 2025-06-04

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Maimonides Medical Center — Brooklyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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