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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My pain level is at least a 5 out of 10.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Side Effect Rating Scale for Dissociative Anesthetics (SERSDA) Score
Secondary outcome measures
Visual Analog Scale (VAS) Score
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience pain in my abdomen, back, sides, muscles, or chest due to injury.I regularly use strong painkillers like fentanyl.I haven't used fentanyl in the last hour or other painkillers in the last 4 hours.I have a history of serious heart problems.My liver or kidneys are not working properly.I am currently experiencing a manic episode.You currently experience strong beliefs or see or hear things that are not real, or have been diagnosed with schizophrenia.My pain level is at least a 5 out of 10.I am fully aware of who I am, where I am, and the current time.I have a thyroid condition that hasn't been treated or controlled.I have recently had a head or eye injury.Your blood pressure, heart rate, or breathing is not within the normal range.I have been diagnosed with high pressure in my brain.You have already participated in this study during a previous visit to the emergency department.You are currently using alcohol or drugs.Changes in your thinking and behavior.You have a known allergy or bad reaction to ketamine.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine 15 Minutes
- Group 2: Ketamine 30 Minutes
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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