Ketamine for Pain Control After Severe Traumatic Injury

NCT04274361 | Completed

• 1 other identifier: PRO#00037017
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hospital Inpatient Trauma Injury; Pain Management

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid morphine equivalent dose

  The cumulative OME will be compared within the two groups.

  The first 24 hours

Study Arms (2)

Ketamine arm

EXPERIMENTAL

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.

Drug: Ketamine

Placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ketamine DRUG

Ketamine infusion

Ketamine arm

Placebo DRUG

Placebo infusion

Placebo arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-64
• ISS \>15
• Infusion can be started within 24 hrs of arrival to FMLH (time of injury irrelevant)
• Admitted to Inpatient hospital trauma service (not Ortho/Plastics/Neurosurgery etc)

You may not qualify if:

• Age \<18 or \>64
• History of adverse reaction to ketamine therapy
• Chronic opioid therapy defined as \> 3 weeks of \>30mg oral morphine equivalents per day
• Current substance abuse with opioids including prescription and/or heroin
• Intubation on arrival or need for urgent intubation on arrival
• GCS \<13, significant traumatic brain injury, or suspicion of elevated intracranial pressure resulting in the patient's inability to communicate
• History of psychosis
• Active delirium
• Glaucoma
• Ischemic heart disease defined as active acute coronary syndrome
• Severe, poorly controlled hypertension (SBP \>200) on more than two readings
• Aortic Injury requiring HR and BP control
• Concurrent use of monoamine oxidase inhibitors (MAOIs)
• Pregnancy
• Prisoners

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.

  PMID: 38767196 DERIVED

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.

  PMID: 35141873 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Thomas Carver, MD

  Medical College of WI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, General Surgery

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: January 20, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 14, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)