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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine-propofol | Experimental |
| |
| Ketamine alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedural sedation with ketamine-propofol combination | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of recovery agitation | Patient will be followed during the procedural sedation, for an average time of thirty minutes after the first injection | Recovery agitation is noted after procedural sedation for each patient (30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from first injection to optimal sedation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabien LEMOEL, MD | CHU de Nice, FRANCE | Principal Investigator |
| Jacques LEVRAUT, PD, MD | CHU de Nice, FRANCE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital St Roch | Nice | 06006 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28493642 | Result | Lemoel F, Contenti J, Giolito D, Boiffier M, Rapp J, Istria J, Fournier M, Ageron FX, Levraut J. Adverse Events With Ketamine Versus Ketofol for Procedural Sedation on Adults: A Double-blind, Randomized Controlled Trial. Acad Emerg Med. 2017 Dec;24(12):1441-1449. doi: 10.1111/acem.13226. Epub 2017 Jul 14. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Procedural sedation with ketamine alone | Drug | 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). |
|
| 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 | 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 | 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 | 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 | 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 | 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 | after procedural sedation, care giver's satisfaction is recorded (30 minutes) |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |