Ketamine Low dOse Evaluation on morphine consumption in traumatic patient : a prospective randomized controlled double-blind study - KLOE

ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE0 个研究点目标入组 140 人开始时间: 2020年11月27日最近更新: 2022年1月24日

适应症

试验速览

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•- 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

•- 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.

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