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

NCT06364540 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2023-08-14
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

pain; acute; emergency medicine; clinical tiral

Outcome Measures

Primary Outcomes (1)

• Reduction of pain scores on the numeric rating pain scale (NRS)

  comparative reduction of pain scores on the numeric rating pain scale (NRS) between recipients of KetaBAN and FentaBAN

  30 minutes

Secondary Outcomes (3)

• Need for Rescue Analgesia

  30-120 minutes

• Severity of Adverse Events

  30-120 minutes

• Evaluation of Severity of agitation and/or sedation

  30-120 minutes

Study Arms (2)

Nebulized KetaBAN

ACTIVE COMPARATOR

Nebulized ketamine administered at 0.75 mg/kg via BAN to adult patients presenting to the ED of Maimonides Medical Center with acute painful conditions of moderate to severe intensity.

Drug: Ketamine

Nebulized FentaBAN

ACTIVE COMPARATOR

Nebulized fentanyl administered at 3 mcg/kg via BAN to adult patients presenting to the ED of Maimonides Medical Center with acute painful conditions of moderate to severe intensity.

Drug: Fentanyl

Interventions

Ketamine DRUG

Nebulized ketamine administered at 0.75 mg/kg via BAN

Also known as: Ketalar

Nebulized KetaBAN

Fentanyl DRUG

Nebulized fentanyl administered at 3 mcg/kg via BAN

Also known as: Sublimaze

Nebulized FentaBAN

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Ketamine; Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonios Likourezos, MA, MPH

CONTACT

718-283-6896; alikourezos@maimo.org

Sergey Motov, MD

CONTACT

718-283-8693; smotov@maimo.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 15, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)