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NMDA Receptor Antagonist

Ketamine for Severe Traumatic Injury Pain Management

N/A
Recruiting
Led By Thomas Carver, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to Inpatient hospital trauma service (not Ortho/Plastics/Neurosurgery etc)
Age 18-64
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the first 24 hours
Awards & highlights

Study Summary

This trial will test if ketamine can help reduce the amount of opioids needed for pain relief in adults with severe injuries.

Who is the study for?
This trial is for adults aged 18-64 who've been hospitalized with severe trauma (ISS >15) and can start treatment within 24 hours of arrival. It's not for those over 64, under 18, with a history of ketamine issues, chronic opioid use, substance abuse, certain heart or brain conditions, glaucoma, pregnancy, severe hypertension, prisoners or if they're on MAOIs.Check my eligibility
What is being tested?
The study tests whether early ketamine infusion reduces the need for opioid painkillers in the first 24 to 48 hours after hospital admission compared to a placebo in adult trauma patients with significant injuries.See study design
What are the potential side effects?
Ketamine may cause side effects such as changes in blood pressure and heart rate, dizziness or feeling light-headed when standing up quickly. Some people might experience unusual dreams or hallucinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am admitted to the hospital for trauma care, not for orthopedic, plastic, or neurosurgery.
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I am between 18 and 64 years old.
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I can start treatment within 24 hours of arriving at the facility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the first 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and the first 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative opioid morphine equivalent dose

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketamine armExperimental Treatment1 Intervention
Early ketamine infusion therapy at a rate of 3 mcg/kg/min. All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal. Ketamine infusion therapy will be continued for 48 hours. At 2-4 hours post-infusion the patient's pain will be reassessed. If the NPS is more than 5 the infusion will be increased to 5mcg/kg/min. Following each change in the infusion rate the patient's pain will be reassessed at 2-4 hours and adjustments made accordingly. Maximum infusion rate will be set at 9mcg/kg/min. Conversely, The RAAPS team should be notified if neurologic symptoms (hallucinations, delusions, disturbing dreams, vertigo) are developing and, at the discretion of the RAAPS service, a single dose of lorazepam or midazolam may be utilized. The infusion can be decreased from in 2 mcg/kg/min increments if there are symptoms believed to be related to the infusion that do not respond to benzodiazepines.
Group II: Placebo armPlacebo Group1 Intervention
The 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,367 Total Patients Enrolled
Thomas Carver, MDPrincipal Investigator - Medical College of WI
Froedtert & The Medical College of Wisconsin
University Of Washington School Of Medicine (Medical School)
Naval Medical Ctr-San Diego (Residency)
1 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04274361 — N/A
Trauma Injury Research Study Groups: Ketamine arm, Placebo arm
Trauma Injury Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT04274361 — N/A
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04274361 — N/A

Frequently Asked Questions

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

Is the trial currently open to new participants?

"Clinicaltrials.gov states that this research is recruiting participants and has been active since its initial posting on April 1st 2021, with the latest edit taking place on December 1st 2021."

Answered by AI

Does the trial accept participants aged seventy or above?

"This clinical trial is recruiting patients that are older than 18 years but younger than 64."

Answered by AI

Is it feasible for me to apply to this clinical experiment?

"This medical investigation is enrolling 130 individuals with pain management issues that are between 18 and 64 years old. Essential requirements include: being within 12 hours of FMLH at the time of recruitment, inpatient hospital admission to trauma services, an ISS score higher than 15 points, and no immediate plans for OR treatment."

Answered by AI

What is the enrollment capacity of this medical research project?

"Affirmative. According to the records hosted on clinicaltrials.gov, this medical experiment is currently recruiting participants as of December 1st 2021. It was originally posted on April 4th 2021 and requires 130 patients from a single site."

Answered by AI
~25 spots leftby Dec 2024