Ketamine hydrochloride for Traumatic injury

Inclusion criteria

• {"criterion_text":"-Male or female over 18"}
• {"criterion_text":"-Trauma patient with 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, Limbs or pelvic girdle, External (entire skin surface) or trauma patient with at least 2 orthopedic lesions in the AIS region \"limbs or pelvic girdle\" combining 2 different limbs or 1 limb and the pelvic girdle."}
• {"criterion_text":"-Patient with at least two regional or orthopedic injuries classified as moderate to maximal, defined by an AIS (Abbreviated Injury Scale) > 1."}
• {"criterion_text":"-Patient with signed informed consent"}
• {"criterion_text":"-Patient entitled to or affiliated with a social security scheme."}

Exclusion criteria

• {"criterion_text":"-Patients with an indication for deep sedation (intracranial hypertension or acute respiratory distress syndrome)."}
• {"criterion_text":"-Presence of a history of psychosis or drug addiction."}
• {"criterion_text":"-Patients with a history of stroke of less than 3 months."}
• {"criterion_text":"-Patients allergic to ketamine or its excipients."}
• {"criterion_text":"-Patients allergic to sufentanil or paracetamol."}
• {"criterion_text":"-Pregnant or breast-feeding women."}
• {"criterion_text":"-Patients who do not understand French."}
• {"criterion_text":"-Patients under guardianship, curatorship or legal protection."}
• {"criterion_text":"-Patients in whom the infusion could not be started within the first 12 hours of initial management in the investigating department."}
• {"criterion_text":"-Patients whose state of consciousness is incompatible with understanding the protocol."}
• {"criterion_text":"-Patients with chronic, unbalanced hypertension."}
• {"criterion_text":"-Patients with severe heart failure (defined as systolic ejection fraction < 30%)."}
• {"criterion_text":"-Patients with a BMI > 35 kg/m² or a weight of over 120 kg."}
• {"criterion_text":"-Patient with chronic analgesic use, defined as opioid derivatives used for more than one week for an intercurrent illness."}
• {"criterion_text":"-Presence of a history of chronic pain."}
• {"criterion_text":"-Presence of a history of epilepsy not controlled by background treatment."}

Primary endpoints

• {"endpoint_text":"-Total dose of sufentanil administered is deferred to 48 hours of management.","definition_or_measurement_approach":"Total cumulative dose of sufentanil administered measured at 48 hours of management (cumulative sufentanil dose at 48 hours)."}

Secondary endpoints

• {"endpoint_text":"-Cumulative dose of opioids administered during the first 5 days of care.","definition_or_measurement_approach":"Total cumulative opioid dose administered over the first 5 days of care."}
• {"endpoint_text":"-Average VAS during the first 5 days of treatment.","definition_or_measurement_approach":"Mean Visual Analogue Scale (VAS) pain score averaged over the first 5 days of treatment."}
• {"endpoint_text":"-Rate of delirium according to the CAM-ICU scale","definition_or_measurement_approach":"Incidence rate of delirium assessed using the CAM-ICU scale during resuscitation period."}
• {"endpoint_text":"-Rate of occurrence and quantification of nausea and/or vomiting using a semi-quantitative method (absent, mild, moderate, severe) previously described","definition_or_measurement_approach":"Incidence and severity of nausea/vomiting quantified by a predefined semi-quantitative scale (absent, mild, moderate, severe)."}
• {"endpoint_text":"-Rate of occurrence of acute urinary retention/urinary globe","definition_or_measurement_approach":"Incidence of acute urinary retention (urinary globe) during the observation period."}
• {"endpoint_text":"-Rate of occurrence of neurological distress (seizure) or hemodynamic distress (rhythm disturbance / cardiac arrest / hypertensive crisis defined as systolic blood pressure > 180mmHg without associated pain factor) or respiratory distress (orotracheal intubation for respiratory distress, use of non-invasive ventilation or high-flow oxygen therapy (>10L) for respiratory distress)","definition_or_measurement_approach":"Incidence of specified serious adverse events: seizure, rhythm disturbance, cardiac arrest, hypertensive crisis (SBP >180 mmHg without associated pain factor), or respiratory distress requiring intubation, non-invasive ventilation, or high-flow oxygen (>10 L)."}
• {"endpoint_text":"-Rate of occurrence of a hepatic complication defined as an increase in liver enzymes (ALAT) of more than 3 times the high normal value, or an increase of more than 100% in initial bilirubin values, or a decrease in factor V below 50% in the absence of an explanation linked to the management of the trauma or hemorrhage.","definition_or_measurement_approach":"Incidence of hepatic complications defined as: ALAT increase >3x upper normal limit, or bilirubin increase >100% from baseline, or factor V <50% unrelated to trauma/hemorrhage management."}
• {"endpoint_text":"-Length of stay in intensive care unit and total length of hospitalization defined as the number of days between the date of admission and discharge from the intensive care unit and hospitalization.","definition_or_measurement_approach":"Number of days between admission and discharge from ICU and total hospital stay (days)."}
• {"endpoint_text":"-Amount of analgesic treatment taken daily, overall quality of life, occurrence and quantification and location of potential chronic pain according to the SF-MPQ-2 and SPRINT and SF-36 questionnaires","definition_or_measurement_approach":"Daily analgesic consumption and patient-reported outcomes assessed by SF-MPQ-2, SPRINT and SF-36 questionnaires; telephone interview at 3 months to evaluate daily analgesic usage, QoL, and chronic pain occurrence/quantification/location."}

France

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

28-05-2025

Processing Time Days

322

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

Assistance Publique Hopitaux De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France