Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

Traumatic Injury Clinical Trial

— KLOE  

Official title:

Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833816
• Other study ID #: 2019-48
• Secondary ID: 2020-004812-81
• Status: Recruiting
• Phase: Phase 3
• Start date: August 5, 2022
• Est. completion date: August 4, 2024

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Gary Duclos, MD
• Phone: 0491965531
• Email: gary.duclos[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 4, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Traumatic Injury
• Wounds and Injuries

Intervention

Drug:
• Administration of drug
Administration of ketamin during the 48h after trauma

Locations

Country	Name	City	State
France	Service Anesthésie Réanimation - Hôpital nord	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of sufentanil	All doses of sufentanil and opiods administration	48 hours
Secondary	Total amount of opiods		5 days
Secondary	Pain assessment		5 days
Secondary	Delirium	Scale CAM-ICU (confusion assesment method)	5 days
Secondary	Global Quality of life	SF-36 score	3 months
Secondary	Chronical pain	SF-MPQ-2	3 months