Traumatic InjuryPhase 3KLOENCT04833816
Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
A Phase 3 study testing Administration of drug in people with Traumatic Injury, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Injury
- What is being tested?
- Administration of drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2022to 3 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Administration of drug
- Keywords
- ketamine, analgesia, ISS, trauma
- Medical subject headings
- Wounds and Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of drugDrug
Administration of ketamin during the 48h after trauma
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Administration of drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of sufentanil
All doses of sufentanil and opiods administration
Measured: 48 hours
Secondary outcomes (5)
Total amount of opiods
Measured: 5 days
Pain assessment
Measured: 5 days
Delirium
Scale CAM-ICU (confusion assesment method)
Measured: 5 days
Global Quality of life
SF-36 score
Measured: 3 months
Chronical pain
SF-MPQ-2
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start5 Aug 2022
- Primary completion4 Oct 2025
- Study completion3 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Olivier ARNAUD, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833816
- Sponsor's protocol ID
- 2019-48
- Other IDs
- 2020-004812-81
- Acronym
- KLOE
- Status last verified
- Feb 2026
- First submitted
- 5 Apr 2021
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42310772
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
- ClinicalTrials.gov ID
- NCT04833816
- Acronym / sponsor ID
- KLOE / 2019-48
- Conditions
- Traumatic Injury
- Keywords
- ketamine, analgesia, ISS, trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 3 Jan 2026 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamin | Experimental | Drug: Administration of drugPatient 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 | Drug: Administration of drugPatient 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of drugAdministration of ketamin during the 48h after trauma | Drug | Ketamin, Placebo |
Primary outcome
Total dose of sufentanil
Time frame: 48 hours
All doses of sufentanil and opiods administration
5 secondary outcomes
Total amount of opiods
Time frame: 5 days
Pain assessment
Time frame: 5 days
Delirium
Time frame: 5 days
Global Quality of life
Time frame: 3 months
Chronical pain
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 42310772Duclos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Olivier ARNAUD study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Administration of drug in people with Traumatic Injury, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dose of sufentanil (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.