Traumatism
Conditions
Interventions
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:
Sponsors
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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' V | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Contacts
Public ContactProject Manager
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Outcome results
None listed