Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient (NCT04833816) | Clinical Trial Compass
CompletedPhase 3
Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient
France140 participantsStarted 2022-08-05
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 unders…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.