Clinical TrialNeurological InjuryKetaminePlaceboCompleted

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

This Phase III interventional trial (n=140) evaluates whether continuous low-dose ketamine infusion reduces morphine consumption by ≥25% at 48 hours in severe trauma patients versus placebo.

Target Enrollment
140 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

1 sessions
2880 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Bolus then continuous low-dose ketamine infusion for 48 hours.

Interventions

  • Ketamine0.1 mg/kg
    via IV• bolus then continuous infusion

    Bolus 0.1 mg/kg then continuous infusion 0.15 mg/kg/hour for 48 hours.

Placebo

inactive

Saline bolus then saline infusion for 48 hours (placebo comparator).

Interventions

  • Placebo0.1 mg/kg
    via IV• bolus then continuous infusion

    Saline bolus 0.1 mg/kg then saline infusion 0.15 mg/kg/hour for 48 hours (per protocol description).

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion 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

  • 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).

Study Details

  • Status
    Completed
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment140 participants
  • Timeline
    Start: 2022-08-05
    End: 2024-08-04
  • Compounds
    KetaminePlacebo
  • Topic
    Neurological Injury

Locations

Service Anesthésie Réanimation - Hôpital nord — Marseille, France

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