Severe acute pain
Conditions
Brief summary
Proportion of patients experiencing at least one psychodysleptic effect, in the control group (ketamine IV 0.3 mg/kg) and in the active group (esketamine IV 0.15 mg/kg). We used the SERSDA (Side Effects Rating Scale for Dissociate Anesthetics) scale, the most widely used in studies, with 9 items. The presence of one of these 9 items will be assessed by patients every 5 minutes from t0 (start of infusion) to t0 + 60 minutes.
Detailed description
Assess the intensity of psychodysleptic effects described by patients, Compare the analgesic efficacy of the 2 molecules during the first hour of treatment: evolution of EN pain scores over time ; proportion of patients reporting relief (EN≤3/10); rate of recourse to additional analgesia (“rescue analgesia”)., Define the proportion of other possible adverse effects or abnormal vital constants measured every 15 minutes from t0 to t0 + 60 minutes.
Interventions
DRUGESKETAMINE IDD 25 mg/mL
DRUGsolution injectable
Sponsors
Centre Hospitalier Universitaire De Nice
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients experiencing at least one psychodysleptic effect, in the control group (ketamine IV 0.3 mg/kg) and in the active group (esketamine IV 0.15 mg/kg). We used the SERSDA (Side Effects Rating Scale for Dissociate Anesthetics) scale, the most widely used in studies, with 9 items. The presence of one of these 9 items will be assessed by patients every 5 minutes from t0 (start of infusion) to t0 + 60 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the intensity of psychodysleptic effects described by patients, Compare the analgesic efficacy of the 2 molecules during the first hour of treatment: evolution of EN pain scores over time ; proportion of patients reporting relief (EN≤3/10); rate of recourse to additional analgesia (“rescue analgesia”)., Define the proportion of other possible adverse effects or abnormal vital constants measured every 15 minutes from t0 to t0 + 60 minutes. | — |
Countries
France
Outcome results
None listed