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NMDA Receptor Antagonist

Ketamine for Acute Pain

Phase 4
Recruiting
Led By Michael Pallaci, DO, FACEP
Research Sponsored by Summa Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary complaint of acute moderate to severe pain on VAS/numeric pain scale (a score of ≥5cm which corresponds to 50mm)
Must be alert and oriented times three
Must not have
Patients who have recent fentanyl use within 60 minutes or other analgesic use (opiates) within 4 hours of study enrollment (signing of consent)
History of unstable heart disease, such as arrhythmias, congestive heart failure, or coronary heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is studying whether a longer or shorter infusion of ketamine reduces side effects in people with severe pain in the emergency department.

Who is the study for?
This trial is for adults over 18 in the Emergency Department with acute, severe pain from conditions like abdominal or musculoskeletal pain. They must be alert, oriented, and able to consent. Excluded are pregnant or breastfeeding individuals, those with altered mental status or unstable vitals, recent drug/alcohol use, certain psychiatric conditions, recent analgesic use, chronic opiate users, and those with specific heart diseases.
What is being tested?
The study tests if a low dose of Ketamine given slowly through an IV over 30 minutes reduces side effects compared to a faster infusion over 15 minutes while still controlling severe pain effectively in emergency situations.
What are the potential side effects?
Ketamine may cause side effects such as feelings of dissociation (feeling detached from reality), changes in blood pressure and heart rate, nausea or vomiting. The trial aims to see if slower infusion rates can reduce these potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain level is at least a 5 out of 10.
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I am fully aware of who I am, where I am, and the current time.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used fentanyl in the last hour or other painkillers in the last 4 hours.
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I have a history of serious heart problems.
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My liver or kidneys are not working properly.
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I am currently experiencing a manic episode.
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I have recently had a head or eye injury.
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I regularly use strong painkillers like fentanyl.
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I have a thyroid condition that hasn't been treated or controlled.
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I have been diagnosed with high pressure in my brain.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Score
Secondary study objectives
Visual Analog Scale (VAS) Score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ketamine 30 MinutesExperimental Treatment1 Intervention
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 30 minutes.
Group II: Ketamine 15 MinutesActive Control1 Intervention
Participants receive 0.25mg/kg Ketamine dose intravenous for pain over 15 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

Summa Health SystemLead Sponsor
30 Previous Clinical Trials
3,147 Total Patients Enrolled
Michael Pallaci, DO, FACEPPrincipal InvestigatorSumma Health System

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05518877 — Phase 4
Depersonalization Research Study Groups: Ketamine 15 Minutes, Ketamine 30 Minutes
Depersonalization Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05518877 — Phase 4
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518877 — Phase 4
~12 spots leftby Aug 2025
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