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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04833816
Recruitment Status : Not yet recruiting
First Posted : April 6, 2021
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Traumatic Injury Drug: Administration of drug Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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




Primary Outcome Measures :
  1. Total dose of sufentanil [ Time Frame: 48 hours ]
    All doses of sufentanil and opiods administration


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833816


Contacts
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Contact: Gary Duclos, MD 0491965531 ext 33 gary.duclos@ap-hm.fr

Locations
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France
Service Anesthésie Réanimation - Hôpital nord
Marseille, France, 13015
Contact: Gary Duclos    0491965531    gary.duclos@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean Olivier ARNAUD AP-HM
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT04833816    
Other Study ID Numbers: 2019-48
2020-004812-81 ( EudraCT Number )
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique Hopitaux De Marseille:
ketamine
analgesia
ISS
trauma
Additional relevant MeSH terms:
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Wounds and Injuries