Evaluation of ketamine on opiods consumption in traumatic patient

INTERVENTION: Trade Name: KETAMINE RENAUDIN 10 mg/mL, solution injectable Product Name: KETAMINE Product Code: N01AX03 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: KETAMINE CAS Number: 1867‐66‐9 Other descriptive name: KETAMINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Therapeutic area: Diseases [C] ‐ Injuries, poisonings, and occupational diseases [C21] Traumatism SECONDARY OUTCOME: Secondary end point(s): ‐ Cumulative dose of opioids administered during the first 5 days of treatment.; ‐ Average VAS during the first 5 days of treatment.; ‐ occurrence of delirium and quantification of nausea/vomiting and urinary retention/urinary globe.; ‐ occurrence of neurological distress or hemodynamic or respiratory ; ‐ occurrence of a hepatic complication defined as an increase of more than 100% in initial bilirubin values ??or a decrease in factor V below 50% in the absence of an explanation related to the management of the trauma or bleeding.; ‐ Duration of stay in intensive care unit and total length of hospitalization defined as the number of days spent between the date of admission and discharge from the intensive care unit and hospitalization.; ‐ amount of analgesic treatment consumed daily, the quality of life, the occurrence and quantification and location of potential chronic pain; Timepoint(s) of evaluation of this end point: 5 days ; Total duration of stay in intensive care; 3 months; INCLUSION CRITERIA: ‐ Male or female adult ‐ Traumatized patient presenting at least 2 lesions on two different regions as defined by the ISS score (injury severity score) (Head, Thorax, Abdomen, Upper limbs, Lower limbs, Spine). ‐ 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range PRIMARY OUTCOME: Main Objective: The main objective of this research is to demonstrate a significant reduction of at least 25% in the consumption of opioids at 48 hours of management of a serious trauma, while demonstrating the non‐inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a group receiving a placebo. Primary end point(s): The total dose of sufentanil administered is postponed to 48 hours of treatment by adding the doses indicated on the self‐administration device and / or of the Priméa® base in the event of continuous administration with the syringe pump. All doses of sufentanil or morphine equivalents administered in the operating room during this period or during any other anesthesia procedures are added.; In the case of oral administration, the doses of oxynorm / oxycontin administered are converted into IV morphine equivalent so that they can be counted for the primary endpoint.; The non‐inferiority character will be judged on the comparison of the mean VAS of the first 48 hours of treatment. Patients' VAS is assessed every 4 hours using a validated standardized ruler device. This systematic assessment will be offered by the registered nurse (IDE) in charge of the patient. The target given to the patient in the self‐controlled administration of sufentanil will be a 30mm VAS. Secondary Objective: ‐ Compare the cumulative doses of opioids administered during the first 5 days of treatment.; ‐ Compare the average VAS during the first 5 days of treatment.; ‐ Compare the rate of occurrence of delirium between the 2 groups occurring during intensive care.; ‐ Compare the rate of occurrence of complications between the 2 groups occurring during intensive care (urinary retention, nausea, vomiting, delirium, hemodynamic instability, hypertensive access, neurological distress (seizure), respiratory distress, change in liver function test ); ‐ Compare the average sedation times between the 2 groups in intensive care.; ‐ Compare the average length of stay between the 2 groups in intensive care and in the hospital.; ‐ Compare the rate of occurrence of chronic pain at 3 months of treatment between the 2 groups using a validated questionnaire.; ‐ Compare the consumption of morphine at 3 months. Timepoint(s) of evaluation of this end point: 48 hours