Using low-dose ketamine to reduce opioid use in trauma patients

Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

This study is testing if low-dose ketamine can help trauma patients use less opioids for pain relief after severe injuries.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (other)
• Locations: 1 site (Marseille)
• Trial ID: NCT04833816 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of low-dose ketamine in reducing opioid consumption by at least 25% within 48 hours in patients with severe traumatic injuries. Participants will receive a continuous infusion of ketamine, while a control group will receive a placebo. The study will also assess whether ketamine provides comparable pain relief to opioids. The focus is on patients with multiple injuries as defined by the Injury Severity Score (ISS).

Who should consider this trial

Good fit: Ideal candidates are adult trauma patients with at least two injuries in different body regions and moderate to severe injury classifications.

Not a fit: Patients requiring deep sedation or those with severe comorbidities such as heart failure or uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce reliance on opioids for pain management in trauma patients, potentially lowering the risk of opioid-related side effects and addiction.

How similar studies have performed: Other studies have shown promising results with ketamine for pain management, suggesting this approach may be effective, though this specific application is less commonly tested.

Eligibility criteria

Inclusion Criteria:

* Male or female adult
* Trauma patient presenting at least 2 lesions in two different regions as defined by the ISS (injury severity score) (Head or neck, Face, Thorax, Abdomen and pelvic contents, Upper limbs or pelvic girdle, Lower limbs, External (any skin surface).
* Patient presenting at least two regional disorders classified as moderate to maximum defined by an AIS (Abbreviated Injury Scale)\> 1.
* Patient having signed an informed consent

Exclusion Criteria:

* Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome).
* Patient in whom the infusion could not be started within the first 6 hours of initial treatment.
* Patient whose state of consciousness is incompatible with understanding the protocol.
* Patient with chronic unbalanced arterial hypertension.
* Patient with severe heart failure.
* Patient with a BMI\> 35 kg / m² or a weight of more than 120 kg.
* Patient with chronic analgesic consumption defined by consumption of opioid derivatives for more than a week for an intercurrent illness.
* Presence of a history of chronic pain.
* Presence of a history of epilepsy.
* Presence of a history of psychosis or drug addiction.
* Presence of a history of stroke.
* Patients with an allergy to the molecule or excipients composing ketamine
* Patients with an allergy to the molecule or to the excipients making up sufentanil or paracetamol.
* Pregnant or breastfeeding woman.
* Patient not understanding French.
* Protected adult patient (under guardianship, curatorship or legal protection).

Where this trial is running

Marseille

• Service Anesthésie Réanimation - Hôpital nord — Marseille, France (RECRUITING)

Study contacts

• Study coordinator: Gary Duclos, MD

Conditions: Traumatic Injury, ketamine, analgesia, ISS, trauma