Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

NCT04833816 | Completed Phase 3

• 2 other identifiers: 2019-482020-004812-81
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

ketamine; analgesia; ISS; trauma

Outcome Measures

Primary Outcomes (1)

• Total dose of sufentanil

  All doses of sufentanil and opiods administration

  48 hours

Secondary Outcomes (5)

• Total amount of opiods

  5 days

• Pain assessment

  5 days

• Delirium

  5 days

• Global Quality of life

  3 months

• Chronical pain

  3 months

Study Arms (2)

Ketamin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Administration of drug DRUG

Administration of ketamin during the 48h after trauma

Ketamin; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service Anesthésie Réanimation - Hôpital nord

Marseille, 13015, France

Location

MeSH Terms

Conditions

Wounds and Injuries; Agnosia

Interventions

Administration, Inhalation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jean Olivier ARNAUD

  AP-HM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 6, 2021
• Study Start: August 5, 2022
• Primary Completion: October 4, 2025
• Study Completion: January 3, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)