Skip to main content
OpenTrials
Completed

NCT Number: NCT04833816

Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service Anesthésie Réanimation - Hôpital nord

Marseille, 13015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Administration of drug

Drug

Administration of ketamin during the 48h after trauma

Primary outcomes

  1. Total dose of sufentanil

    Time frame: 48 hours

    All doses of sufentanil and opiods administration

Secondary outcomes

  1. Total amount of opiods

    Time frame: 5 days

  2. Pain assessment

    Time frame: 5 days

  3. Delirium

    Time frame: 5 days

    Scale CAM-ICU (confusion assesment method)

  4. Global Quality of life

    Time frame: 3 months

    SF-36 score

  5. Chronical pain

    Time frame: 3 months

    SF-MPQ-2

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: KLOE

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2021
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.