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NMDA Receptor Antagonist

Ketamine for Severe Traumatic Injury Pain Management

N/A

Waitlist Available

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

Must not have

Concurrent use of monoamine oxidase inhibitors (MAOIs)

Intubation on arrival or need for urgent intubation on arrival

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the first 24 hours

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking MAOI medications.

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I needed a breathing tube when I arrived or shortly after.

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I have glaucoma.

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I have an aortic injury that needs heart rate and blood pressure management.

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I have been on strong painkillers for more than 3 weeks.

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I am younger than 18 or older than 64.

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My blood pressure is often above 200 despite taking medication.

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I have an active heart condition related to reduced blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the first 24 hours

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

~1120

0 / 11Eligibility criteria met