93 Participants Needed

Ketamine for Severe Traumatic Injury Pain Management

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Overseen ByMargo Mantz-Wichman, BS, RN
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates if the early utilization of ketamine infusion therapy among acutely injured adult trauma hospital inpatients with an ISS \>15 will decrease the amount of opioid pain medication used as compared with placebo group. Ketamine infusion therapy initiated within 12 hours of hospital arrival will lead to decreased total opiate consumption (standardized to oral morphine equivalent units) in the first 24 and 48 hours compared to controls.

Who Is on the Research Team?

TC

Thomas Carver, MD

Principal Investigator

Medical College of WI

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am admitted to the hospital for trauma care, not for orthopedic, plastic, or neurosurgery.
I can start treatment within 24 hours of arriving at the facility.
Your cancer is in advanced stages, with a high amount of cancerous cells.

Exclusion Criteria

Prisoners
Current substance abuse with opioids including prescription and/or heroin
I am currently taking MAOI medications.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

24 hours

Treatment

Participants receive ketamine infusion therapy or placebo for pain control

48 hours
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketamine armExperimental Treatment1 Intervention
Group II: Placebo armPlacebo Group1 Intervention

Ketamine is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Ketalar for:
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Approved in European Union as Ketalar for:
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Approved in United States as Spravato for:
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Approved in European Union as Spravato for:
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Approved in Canada as Spravato for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+
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