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
Status Recruiting
Results Published No
Start date 05 August 2022
End date 04 August 2024
Phase Phase III
Design Blinded
Type Interventional
Generation First
Participants 140
Sex All
Age 18- 75
Therapy No

Trial Details

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.

NCT Number NCT04833816

Data attribution

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