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| ID | Type | Description | Link |
|---|---|---|---|
| 0272-08-TLV | |||
| Study Protocol [1] 2-Jul-08 |
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The use of procedural sedation and analgesia (PSA) to accomplish painful procedures in the emergency department (ED) has become a standard of practice over the last decade. Substantial variance exists regarding usage of medication for PSA, and many anesthetic agents have been proposed for this use.
To our knowledge no head to head study compared the clinical effectiveness, safety profile and amnestic properties of midazolam/ketamine vs. propofol regimens for PSA in the adult ED setting.
This prospective randomized trail can will help to evaluate the effectiveness and safety profile of Midazolam/katamine regimen for ED PSA in adults and will contribute to the discussion regarding propofol roll in the ED.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midazolam/ketamine | Active Comparator | Patients with orthopedic injuries requiring painful manipulation |
|
| propofol | Active Comparator | Patients with orthopedic injuries requiring painful manipulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine/Midazolam | Drug | Intravenous bolus of midazolam 0.1mg/kg in titrated dose of 1 mg/min until spontaneous eye closure or up to 5mg (whichever comes first) followed by ketamine 0.5-1mg/kg (up to 100mg) in titrated dose of 10mg/30 seconds, to achieve the desired level of sedation |
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness and safety profile of procedural sedation using propofol versus midazolam/ketamine. | outcome measures will be monitored continuously and will be documented every few minutes from initiating sedation until the patient returns to his/her basic mental status |
| Measure | Description | Time Frame |
|---|---|---|
| The amnestic properties of procedural sedation with propofol versus midazolam/ketamine. | Recall issues will be assessed after the patient returns to his/her basic mental status and within 72 hours from the procedure (either on a follow up visit or by a phone call) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pinchas Halpern, MD | Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008874 | Midazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Propofol | Drug | Intravenous bolus of propofol 0.5-1mg/kg in titrated dose of 10mg/30seconds (up to 100mg) to achieve the desired level of sedation |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |