Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Apr 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of low-dose ketamine on pain management for patients who have experienced severe traumatic injuries. The goal is to see if using ketamine can help reduce the amount of opioids (pain medication) needed by at least 25% within the first 48 hours after the injury, while still providing effective pain relief. The trial is looking for adults aged 18 and older who have multiple injuries from trauma, such as those to different parts of the body. Participants must also be able to understand the study and provide consent.

If you or a loved one are considering participation, you can expect to receive either a continuous infusion of low-dose ketamine or a placebo (which doesn’t contain active medication) over a 48-hour period. This study is currently recruiting participants, and it’s important to note that there are specific health conditions that may exclude someone from joining, such as severe heart problems or a history of certain medical conditions. Overall, this trial aims to improve pain management strategies for trauma patients, potentially leading to safer and more effective treatment options.

Gender

ALL

Eligibility criteria

• 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).