Ketamine Low dOse Evaluation on morphine consumption in traumatic patient

Phase 1

• Conditions: Traumatism; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: CTIS2023-510016-39-00
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-05
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Male or female over 18, 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., Patient with at least two regional or orthopedic injuries classified as moderate to maximal, defined by an AIS (Abbreviated Injury Scale) > 1., Patient with signed informed consent, Patient entitled to or affiliated with a social security scheme.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified