Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient (KLOE)

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Completed; Phase 3

Conditions: Traumatic Injury

Treatments: Drug: Administration of drug

Study type: Interventional

Funder types: Other

Identifiers

NCT04833816

2020-004812-81 (EudraCT Number)

2019-48

Details and patient eligibility

About

The aim of this study is to demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours of management of severe trauma, while demonstrating non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a placebo group.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Ketamin

Experimental group

Description:

Patient will get a bolus of ketamine at 0.1 mg / kg followed by a continuous infusion of ketamine at a dose of 0.15 mg / kg / hour

Treatment:

Drug: Administration of drug

Placebo

Placebo Comparator group

Description:

Patient will get a bolus of NaCL at 0.1 mg / kg followed by a continuous infusion of NaCl at a dose of 0.15 mg / kg / hour

Treatment:

Drug: Administration of drug