Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

NCT ID: NCT04833816

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2026-01-03

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.

Conditions

Traumatic Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Administration of drug

Intervention Type: DRUG

Administration of ketamin during the 48h after trauma

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

Group Type: PLACEBO_COMPARATOR

Administration of drug

Intervention Type: DRUG

Administration of ketamin during the 48h after trauma

Interventions

Administration of drug

Administration of ketamin during the 48h after trauma

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Olivier ARNAUD

Role: STUDY_DIRECTOR

AP-HM

Locations

Service Anesthésie Réanimation - Hôpital nord

Marseille, , France

Countries

France

Other Identifiers

2020-004812-81

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2019-48

Identifier Type: -

Identifier Source: org_study_id