Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004812-81 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of drug | Drug | Administration of ketamin during the 48h after trauma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of sufentanil | All doses of sufentanil and opiods administration | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of opiods | 5 days | |
| Pain assessment | 5 days | |
| Delirium |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean Olivier ARNAUD | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Anesthésie Réanimation - Hôpital nord | Marseille | 13015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42310772 | Derived | Duclos G, Resseguier N, Arbelot C, Pastene B, Zieleskiewicz L, Leone M. Ketamine Low dOse Evaluation on morphine consumption in traumatic patients: study protocol for a randomized, double-blind, placebo-controlled trial (KLOE-Trial). Scand J Trauma Resusc Emerg Med. 2026 Jun 17. doi: 10.1186/s13049-026-01649-7. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000280 | Administration, Inhalation |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Scale CAM-ICU (confusion assesment method)
| 5 days |
| Global Quality of life | SF-36 score | 3 months |
| Chronical pain | SF-MPQ-2 | 3 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |