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Ketamine Low dOse Evaluation on morphine consumption in traumatic patient

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510016-39-00
Acronym
RCAPHM19_0374
Enrollment
140
Registered
2024-07-31
Start date
2022-08-05
Completion date
Unknown
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatism

Brief summary

Total dose of sufentanil administered is deferred to 48 hours of management.

Detailed description

Cumulative dose of opioids administered during the first 5 days of care., Average VAS during the first 5 days of treatment., Rate of delirium according to the CAM-ICU scale, Rate of occurrence and quantification of nausea and/or vomiting using a semi-quantitative method (absent, mild, moderate, severe) previously described, Rate of occurrence of acute urinary retention/urinary globe, Rate of occurrence of neurological distress (seizure) or hemodynamic distress (rhythm disturbance / cardiac arrest / hypertensive crisis defined as systolic blood pressure > 180mmHg without associated pain factor) or respiratory distress (orotracheal intubation for respiratory distress, use of non-invasive ventilation or high-flow oxygen therapy (>10L) for respiratory distress), Rate of occurrence of a hepatic complication defined as an increase in liver enzymes (ALAT) of more than 3 times the high normal value, or an increase of more than 100% in initial bilirubin values, or a decrease in factor V below 50% in the absence of an explanation linked to the management of the trauma or hemorrhage., Length of stay in intensive care unit and total length of hospitalization defined as the number of days between the date of admission and discharge from the intensive care unit and hospitalization., Amount of analgesic treatment taken daily, overall quality of life, occurrence and quantification and location of potential chronic pain according to the SF-MPQ-2 and SPRINT and SF-36 questionnaires

Interventions

DRUGplacebo ketamine inj prep
DRUGsolution injectable

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Total dose of sufentanil administered is deferred to 48 hours of management.

Secondary

MeasureTime frame
Cumulative dose of opioids administered during the first 5 days of care., Average VAS during the first 5 days of treatment., Rate of delirium according to the CAM-ICU scale, Rate of occurrence and quantification of nausea and/or vomiting using a semi-quantitative method (absent, mild, moderate, severe) previously described, Rate of occurrence of acute urinary retention/urinary globe, Rate of occurrence of neurological distress (seizure) or hemodynamic distress (rhythm disturbance / cardiac arrest / hypertensive crisis defined as systolic blood pressure > 180mmHg without associated pain factor) or respiratory distress (orotracheal intubation for respiratory distress, use of non-invasive ventilation or high-flow oxygen therapy (>10L) for respiratory distress), Rate of occurrence of a hepatic complication defined as an increase in liver enzymes (ALAT) of more than 3 times the high normal value, or an increase of more than 100% in initial bilirubin values, or a decrease in factor V below 5

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026