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NMDA Receptor Antagonist

Nebulized vs. IV Ketamine for Pain

Phase 4
Waitlist Available
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
ED patients
pain with a score of 5 or more on a standard 11- point (0 to 10) numeric rating scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Study Summary

This trial will help to establish the most efficacious route and dose of ketamine for acute pain management in the ED.

Who is the study for?
This trial is for adults in the emergency department who can understand and consent to the study, are awake and alert, have acute or chronic pain with a severity of at least 5 on a scale of 0-10. It's not for those allergic to ketamine, pregnant, unable to consent, over 150 kg, with unstable vital signs or certain mental health histories.Check my eligibility
What is being tested?
The study tests if intravenous ketamine (0.3 mg/kg) provides better pain relief after 30 minutes compared to nebulized ketamine (0.75 mg/kg) using a Breath-Actuated Nebulizer. The main goal is seeing which method more effectively reduces pain scores.See study design
What are the potential side effects?
Ketamine may cause side effects like changes in blood pressure and heart rate, dizziness, nausea, disorientation or hallucinations. When inhaled via BAN or given intravenously at sub-dissociative doses these effects might vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Patients with erectile dysfunction.
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You are experiencing moderate to severe pain, rated as 5 or higher on a scale of 0 to 10.
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You have both short-term and long-term painful conditions.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in in pain score at 30 minutes

Trial Design

2Treatment groups
Active Control
Group I: IV SDKActive Control1 Intervention
intravenous ketamine administration in sub-dissociative doses (SDK) administered at 0.3 mg/kg over 15 minutes to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions.
Group II: K-BANActive Control1 Intervention
nebulized ketamine at 0.75mg/kg administered via BAN to patients presenting to the ED of Maimonides Medical Center with acute and chronic painful conditions.

Find a Location

Who is running the clinical trial?

Antonios LikourezosLead Sponsor
37 Previous Clinical Trials
8,278 Total Patients Enrolled
17 Trials studying Pain
1,275 Patients Enrolled for Pain
Sergey Motov, MDPrincipal InvestigatorMaimonides Medical Center
15 Previous Clinical Trials
1,215 Total Patients Enrolled
10 Trials studying Pain
795 Patients Enrolled for Pain

Media Library

Ketamine via BAN (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04947085 — Phase 4
Pain Research Study Groups: IV SDK, K-BAN
Pain Clinical Trial 2023: Ketamine via BAN Highlights & Side Effects. Trial Name: NCT04947085 — Phase 4
Ketamine via BAN (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04947085 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitments currently underway for this research project?

"Confirmed. According to clinicaltrials.gov, the trial was initiated on October 4th 2021 and has been actively recruiting since then - with a most recent update of October 19th 2022. This medical study will require 150 participants at one location."

Answered by AI

Has K-BAN received the green light from regulatory bodies?

"As this is a Phase 4 drug trial, the safety of K-BAN has been confirmed and thus it receives a score of 3 on our team's scale."

Answered by AI

For what demographic is enrollment in this trial open?

"This clinical trial is seeking 150 individuals aged 18-120 suffering from pain. Applicants must be awake, oriented to their person, place and time, able to communicate any adverse effects they experience and measure the severity of their symptoms via a 0-10 numerical rating scale (NRS), with 5 or more as an indicator for eligibility. Furthermore, acute and chronic painful conditions in both emergency department patients are being considered."

Answered by AI

Is the current research endeavor accepting participants aged eighty-five and above?

"This medical trial requires subjects to be between 18 and 120 years of age. Those who don't meet this criteria may find there are 83 other studies available for minors, or 329 research initiatives suitable for seniors."

Answered by AI

What is the aggregate number of individuals signing up for this research project?

"Affirmative. Evidence hosted on clinicaltrials.gov indicates that this medical trial, whose commencement was October 4th of 2021, is still recruiting participants. Specifically, the research team needs to find 150 people at one site to join their study."

Answered by AI
~44 spots leftby Mar 2025