Ketamine for Severe Traumatic Injury Pain Management

Overseen By Margo Mantz-Wichman, BS, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Opioids, MAOIs

Disqualifiers: Psychosis, Glaucoma, Hypertension, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

93 Participants Needed

Trial Summary

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.

Research Team

Thomas Carver, MD

Principal Investigator

Medical College of WI

Eligibility Criteria

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 am between 18 and 64 years old.

I can start treatment within 24 hours of arriving at the facility.

Exclusion Criteria

Prisoners

Current substance abuse with opioids including prescription and/or heroin

I am currently taking MAOI medications.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Ketamine arm Experimental Treatment 1 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 arm Placebo Group 1 Intervention

The 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent.

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

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+