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Nebulized Ketamine vs Fentanyl for Acute Pain (KETAFEN Trial)

Phase 4
Recruiting
Led By Sergey Motov, MD
Research Sponsored by Antonios Likourezos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 64 years
Acute painful condition
Must not have
Administration of opioids or opioid antagonist/agonist within 4-6 hours prior to arrival and NSAIDs 6 hours prior to arrival
Inability to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-120 minutes
Awards & highlights

Summary

This trial is looking at using a device called a breath-actuated nebulizer to deliver pain-relieving medications like ketamine and fentanyl to patients in the emergency department. The study aims to

Who is the study for?
Adults aged 18-64 in the ED with acute pain who can rate their pain as 5 or higher on a scale, are awake and aware, understand the study's consent process, and can communicate any side effects they experience.
What is being tested?
The trial is testing nebulized ketamine against nebulized fentanyl for emergency department patients. It aims to see which one is better at managing pain when IV access isn't available or practical.
What are the potential side effects?
Ketamine may cause dizziness, nausea, changes in blood pressure, disorientation or vivid dreams. Fentanyl might lead to similar issues but also carries a risk of respiratory depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 64 years old.
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I am currently experiencing severe pain.
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My pain level is 5 or higher on a scale of 0 to 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken opioids or NSAIDs within 6 hours before coming.
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I am unable to give consent by myself.
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I have a head injury.
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I need immediate care for a painful condition.
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I weigh more than 100 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction of pain scores on the numeric rating pain scale (NRS)
Secondary study objectives
Evaluation of Severity of agitation and/or sedation
Need for Rescue Analgesia
Severity of Adverse Events

Trial Design

2Treatment groups
Active Control
Group I: Nebulized KetaBANActive Control1 Intervention
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.
Group II: Nebulized FentaBANActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Antonios LikourezosLead Sponsor
39 Previous Clinical Trials
8,344 Total Patients Enrolled
3 Trials studying Acute Pain
370 Patients Enrolled for Acute Pain
Sergey Motov, MDPrincipal InvestigatorMaimonides Medical Center
17 Previous Clinical Trials
1,445 Total Patients Enrolled
2 Trials studying Acute Pain
250 Patients Enrolled for Acute Pain
~100 spots leftby Jun 2026
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