Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient (KLOE)

This Phase III interventional trial (n=140) aims to evaluate the effect of low-dose ketamine on morphine consumption in traumatic patients.

Conducted by Assistance Publique Hopitaux De Marseille, the study seeks to demonstrate a significant reduction of at least 25% in opioid consumption within 48 hours of managing severe trauma. The trial aims to ascertain whether continuous infusion of low-dose ketamine is non-inferior to placebo in terms of analgesia. Eligible participants are adult trauma patients with at least two lesions in different regions and two regional disorders classified as moderate to maximum. Exclusion criteria include chronic pain history, epilepsy, psychosis or drug addiction, allergy to ketamine or its excipients, pregnancy, and inability to understand French.

The study employs a randomised, parallel assignment design with quadruple masking. Participants are allocated to receive either ketamine or placebo. The primary outcome measure is the total dose of sufentanil administered within 48 hours, while secondary measures include total opioid consumption over five days, pain assessment, delirium incidence, quality of life, and chronic pain assessment at three months post-treatment.

Recruitment began on August 5, 2022, and the primary completion date is estimated to be May 5, 2024, with a study completion date projected for August 4, 2024. The trial is conducted at Hôpital Nord, Marseille, France.

Topic Pain
Compound Placebo Ketamine
Country France
Visit trial

Trial Details



Trial Number

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.