Traumatic Injury
Conditions
Keywords
ketamine, analgesia, ISS, trauma
Brief summary
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.
Interventions
Administration of ketamin during the 48h after trauma
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of sufentanil | 48 hours | All doses of sufentanil and opiods administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of opiods | 5 days | — |
| Pain assessment | 5 days | — |
| Delirium | 5 days | Scale CAM-ICU (confusion assesment method) |
| Global Quality of life | 3 months | SF-36 score |
| Chronical pain | 3 months | SF-MPQ-2 |
Countries
France
Contacts
STUDY_DIRECTORJean Olivier ARNAUD
AP-HM
Outcome results
None listed