Back to results

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

Primary Purpose

Traumatic Injury

Status

Recruiting

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Administration of drug

About this trial

This is an interventional treatment trial for Traumatic Injury focused on measuring ketamine, analgesia, ISS, trauma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Service Anesthésie Réanimation - Hôpital nordRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total dose of sufentanil

All doses of sufentanil and opiods administration

Secondary Outcome Measures

Total amount of opiods

Pain assessment

Delirium

Scale CAM-ICU (confusion assesment method)

Global Quality of life

SF-36 score

Chronical pain

SF-MPQ-2

Full Information

NCT ID

NCT04833816

First Posted

April 5, 2021

Last Updated

July 20, 2023

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT04833816

Brief Title

Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

Acronym

KLOE

Official Title

Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 5, 2022 (Actual)

Primary Completion Date

May 5, 2024 (Anticipated)

Study Completion Date

August 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Injury

Keywords

ketamine, analgesia, ISS, trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ketamin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Administration of drug

Intervention Description

Administration of ketamin during the 48h after trauma

Primary Outcome Measure Information:

Title

Total dose of sufentanil

Description

All doses of sufentanil and opiods administration

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Total amount of opiods

Time Frame

5 days

Title

Pain assessment

Time Frame

5 days

Title

Delirium

Description

Scale CAM-ICU (confusion assesment method)

Time Frame

5 days

Title

Global Quality of life

Description

SF-36 score

Time Frame

3 months

Title

Chronical pain

Description

SF-MPQ-2

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gary Duclos, MD

Phone

0491965531

Ext

gary.duclos@ap-hm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Olivier ARNAUD

Organizational Affiliation

AP-HM

Official's Role

Study Director

Facility Information:

Facility Name

Service Anesthésie Réanimation - Hôpital nord

City

Marseille

ZIP/Postal Code

13015

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gary Duclos

Phone

0491965531

gary.duclos@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

We'll reach out to this number within 24 hrs