Evaluation of ketamine on opiods consumption in traumatic patient

Phase 1

• Conditions: Traumatism; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2020-004812-81-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-27
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

- Male or female adult
- Traumatized patient presenting at least 2 lesions on two different regions as defined by the ISS score (injury severity score) (Head, Thorax, Abdomen, Upper limbs, Lower limbs, Spine).
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

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 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.
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified