Recruiting

Ketamine vs. Fentanyl

Sponsor:

Antonios Likourezos

Code:

NCT06364540

Conditions

Pain, Acute

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketamine

Fentanyl

Study Details

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

Study ID

NCT06364540

Start date

May 1, 2024

Status verified date

May, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Nebulized KetaBAN

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.

active comparator: Nebulized FentaBAN

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.

Interventions

Ketamine

Nebulized ketamine administered at 0.75 mg/kg via BAN

Fentanyl

Nebulized fentanyl administered at 3 mcg/kg via BAN

Primary outcome measure

  • Reduction of pain scores on the numeric rating pain scale (NRS) [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Antonios Likourezos, MA, MPH

718-283-6896alikourezos@maimo.org

Sergey Motov, MD

718-283-8693smotov@maimo.org

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Sergey Motov, MD

smotov@maimo.org

Antonios Likourezos, MPH

alikourezos@maimo.org

More Information

Sponsor

Antonios Likourezos

Last update posted

Jun 4, 2025

Last verified

May, 2025

Keywords

  • pain
  • acute
  • emergency medicine
  • clinical tiral

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Antonios Likourezos on 2025-06-04.