Ketamine Low-dose Evaluation on Morphine... — Clinical Trial Details

Randomised, parallel-group, quadruple-blind Phase III trial comparing low-dose ketamine (bolus 0.1 mg/kg then 0.15 mg/kg/hr infusion for 48 hours) with placebo in traumatic patients to reduce opioid consumption.

Primary outcome is reduction in opioid (morphine) consumption at 48 hours; analgesia non-inferiority and safety/tolerability will also be assessed.

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).

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Ketamine Low-dose Evaluation on Morphine Consumption in Traumatic Patients (KLOE)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Ketamine

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators