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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-120 minutes

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 8Eligibility criteria met