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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Injury
• Intervention / Treatment: Drug: Administration of drug

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13015
    • Service Anesthésie Réanimation - Hôpital nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamin; Patient will get a bolus of ketamine at 0.1 mg / kg followed by a continuous infusion of ketamine at a dose of 0.15 mg / kg / hour	Drug: Administration of drug; Administration of ketamin during the 48h after trauma
Placebo Comparator: Placebo; Patient will get a bolus of NaCL at 0.1 mg / kg followed by a continuous infusion of NaCl at a dose of 0.15 mg / kg / hour	Drug: Administration of drug; Administration of ketamin during the 48h after trauma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of sufentanil	All doses of sufentanil and opiods administration	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of opiods		5 days
Pain assessment		5 days
Delirium	Scale CAM-ICU (confusion assesment method)	5 days
Global Quality of life	SF-36 score	3 months
Chronical pain	SF-MPQ-2	3 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Jean Olivier ARNAUD, AP-HM

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): October 4, 2025
• Study Completion (Actual): January 3, 2026

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: trauma; ketamine; analgesia; ISS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wounds and Injuries; Agnosia; Therapeutics; Drug Administration Routes; Drug Therapy; Administration, Inhalation
• Other Study ID Numbers: 2019-48; 2020-004812-81 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No