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Needle-Free pain relief: inhaled ketamine takes on fentanyl in the ER

NCT ID NCT06364540

Symptom relief Sponsor: Antonios Likourezos Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers compare two inhaled pain medicines, ketamine and fentanyl, for adults who arrive at the emergency department with acute pain. Participants receive one of the two drugs through a breath-actuated nebulizer, a device that delivers medicine as they breathe. The trial measures how much pain scores drop over two hours and tracks side effects such as dissociation or sedation. The goal is to see whether inhaled ketamine offers a needle-free alternative that works as well as inhaled fentanyl.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nebulized ketamine and nebulized fentanyl
What this could lead to
If nebulized ketamine works as well as nebulized fentanyl, it could give emergency doctors another needle-free option for rapid pain relief.
What could go wrong
This is a single-center Phase 4 trial with 150 adults, so results may not apply to children, other settings, or different pain types. Ketamine can cause dissociation, sedation, or blood pressure changes, and fentanyl can slow breathing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Acute Pain Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pain, acute

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Maimonides Medical Center

    RECRUITING

    Brooklyn, New York, 11219, United States

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