A Phase 4 interventional study of Procedural sedation with ketamine-propofol combination and Procedural sedation with ketamine alone in Fracture and Dislocation, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 4, Interventional, and Treatment
Using Ketamine for procedural sedation in adults is often uncomfortable for emergency physicians because of the significant proportion of patients experimenting recovery agitation. The investigators believe that combining propofol to ketamine, the proportion of recovery agitation will be significantly lowered.
The objectives of this double-blinded, randomized controlled trial are to compare the proportion of recovery agitation in adults receiving procedural sedation with ketamine-propofol versus ketamine alone, and to compare the proportion of other classical procedural sedation side-effects and parameters such as respiratory depression, hypotension, sedation duration, time of recovery, procedural failures, and levels of satisfaction.
Exclusion Criteria:
Drug: Procedural sedation with ketamine-propofol combination
Drug: Procedural sedation with ketamine alone
K= Kétamine P= Propofol RSS= Ramsay Sedation Score At t0: 0.5 mg/kg of K (0.1 ml/kg of 5 mg/ml K) followed by 0.5 mg/k of P (0.1 ml/kg of 5 mg/ml P). At t0 + 4 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P). At t0 + 8 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P). At t0 + 12 min, if maximal doses have been reached (1 mg/kg of K + 1 mg/kg of P) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver).
K= Ketamine I= Intralipid placebo At t0: 1 mg/kg of K (0.1 ml/kg of 10 mg/ml K), followed by 0.1 ml/kg of I (physical placebo of propofol in the other arm). At t0 + 4 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I. At t0 + 8 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I. At t0 + 12 min, if maximal doses have been used (2 mg/kg of K) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver).
Proportion of recovery agitation
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Time frame: Recovery agitation is noted after procedural sedation for each patient (30 minutes)
Time from first injection to optimal sedation
Time frame: Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection (30 minutes)
Proportion of respiratory depression
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Time frame: respiratory depression is assessed during procedural sedation for each patient (30 minutes)
Proportion of arterial hypotension
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Time frame: Hypotension is assessed during procedural sedation for each patient (30 minutes)
Proportion of vomiting
Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
Time frame: vomiting is assessed after procedural sedation for each patient (30 minutes)
Recovery time
Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
Time frame: Recovery time is assessed after procedural sedation for each patient (30 minutes)
Proportion of procedural failures
Patient will be followed duriong the procedural sedation, for an average time of thirty minutes after the first injection
Time frame: Procedural failure is noted for each patient if it's happened (30 minutes)
Level of patient's satisfaction
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Time frame: after procedural sedation, patient's satisfaction is recorded (30 minutes)
Level of care giver's satisfaction
Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection
Time frame: after procedural sedation, care giver's satisfaction is recorded (30 minutes)
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice