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Study on Ketamine and Sodium Chloride for Reducing Morphine Use in Patients with Severe Trauma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Ketamine Renaudin on patients who have experienced severe injuries, known as trauma. Trauma can involve multiple injuries in different parts of the body, such as the head, neck, chest, abdomen, or limbs. The study aims to see if using a low dose of ketamine can reduce the need for other pain medications, specifically opioids, by at least 25% within the first 48 hours after the injury, while still providing effective pain relief.

Participants in the study will receive either the ketamine treatment or a placebo, which is an inactive substance. The ketamine is given as an injection, and the study will monitor the total amount of pain medication needed, as well as other factors like pain levels, any side effects such as nausea or delirium, and overall recovery. The study will also look at how long patients stay in the hospital and their quality of life after treatment.

The goal is to find out if ketamine can help manage pain more effectively in trauma patients, potentially leading to better outcomes and less reliance on opioids, which are strong painkillers that can have significant side effects. This research could provide valuable insights into improving pain management strategies for people who have suffered serious injuries.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is determined based on specific criteria, including age over 18 and having certain types of injuries.

    Informed consent is required to participate in the study.

  2. Step 2

    Initial treatment phase

    Participants receive either a placebo or ketamine injection. The ketamine used is a solution with a concentration of 10 mg/ml.

    The goal is to evaluate the effect of low-dose ketamine on reducing opioid consumption.

  3. Step 3

    48-hour evaluation

    The primary objective is to assess a reduction in opioid consumption by at least 25% within 48 hours.

    The total dose of sufentanil, an opioid, administered is recorded.

  4. Step 4

    5-day follow-up

    Cumulative opioid doses are monitored over the first 5 days.

    Pain levels are measured using the VAS (Visual Analogue Scale).

  5. Step 5

    Monitoring side effects

    Potential side effects such as nausea, vomiting, delirium, and urinary retention are observed.

    Neurological, hemodynamic, and respiratory distress are also monitored.

  6. Step 6

    Liver function assessment

    Liver enzyme levels are checked to identify any hepatic complications.

    Changes in bilirubin and factor V levels are evaluated.

  7. Step 7

    Hospitalization duration

    The length of stay in the intensive care unit and total hospitalization time are recorded.

  8. Step 8

    Quality of life assessment

    Quality of life and chronic pain are assessed using specific questionnaires like SF-MPQ-2, SPRINT, and SF-36.

Who can join the trial?

5 criteria

  • Must be a male or female over 18 years old.
  • Must be a trauma patient with at least two injuries in two different body areas. These areas can include the head or neck, face, chest, abdomen and pelvic contents, limbs or pelvic girdle, or the entire skin surface. Alternatively, the patient can have at least two bone-related injuries in the limbs or pelvic girdle, involving two different limbs or one limb and the pelvic girdle.
  • Must have at least two injuries that are considered moderate to very severe. This is determined by a score called the Abbreviated Injury Scale (AIS), which should be greater than 1.
  • Must have signed a document called informed consent, which means they agree to participate in the study after understanding what it involves.
  • Must be entitled to or affiliated with a social security scheme, which is a system that provides financial support for healthcare.

Who cannot join the trial?

4 criteria

  • Patients who have a medical condition called traumatism, which refers to injuries or wounds caused by an external force.
  • Patients who are not within the specified age range for the study.
  • Patients who do not belong to the specific clinical trial group required for the study.
  • Patients who are part of a vulnerable population, meaning they may have additional risks or challenges that make participation in the study unsuitable.
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Investigated drugs

Ketamine is being studied to see if it can help reduce the amount of opioids needed for pain management in patients with severe trauma. The trial aims to show that using ketamine can decrease opioid consumption by at least 25% within 48 hours, while still providing effective pain relief.

What is already known about the treatment

Ketamine – Ketamine is typically administered intravenously or intramuscularly. It is currently being studied for its potential to reduce opioid consumption in patients with severe trauma. The main therapeutic indication for ketamine in this context is pain management. At the molecular level, ketamine works by blocking NMDA receptors in the brain, which are involved in pain transmission and perception. It is classified as a dissociative anesthetic.

Investigated diseases

Traumatism – Traumatism refers to physical injuries or wounds caused by external forces, such as accidents, falls, or violence. These injuries can affect any part of the body and vary in severity from minor cuts and bruises to severe fractures and internal damage. The progression of traumatism depends on the nature and extent of the injury, with some cases leading to complications like infections or chronic pain. Immediate symptoms often include pain, swelling, and limited mobility in the affected area. Over time, the body may heal naturally, but some injuries might require medical intervention to prevent further complications. Recovery can involve a combination of rest, rehabilitation, and monitoring for any signs of delayed healing or additional issues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510016-39-00Protocol codeRCAPHM19_0374Estimated enrolment140 patientsSponsorAssistance Publique Hopitaux De Marseille

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