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Ketamine Low dOse Evaluation on morphine consumption in traumatic patient
EU CTIS ID: 2023-510016-39-00
What this study is testing
Demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours in the management of severe trauma, while demonstrating non-inferiority in terms of analgesia.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.