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the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on pain control in trauma patients with closed limb fracture(s); and also compared the incidence of adverse events (mainly cardio pulmonary ) between two groups.
this prospective, single blind, noninferiority trial randomized consecutive ED patients aged 18 to 60 years to two groups: receiving either 300-500 mcg ketamine plus 0.03 mg midazolam, or 0.05 to 0.1 mg morphine. Visual analogue score and adverse events were carefully verified during an interval of 30 minutes.
Two hundreds, thirty six patients were selected, among whom were 207 males (87.3%), and 29 females (12.2%). The average age was 29±2, with extremes of 60 years and 18 years.the patients were divided into two groups: G1: 116 patients receiving ketamine-midazolam and G2: 120 patients receiving morphine alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine-midazolam | Experimental | 300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam |
|
| Morphine | Active Comparator | 0.05 to 0.1 mg/kg morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine-midazolam | Drug | Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAPS | the pain score was verified at the outset and every 10 minutes after administration of analgesics. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| HR,RR,SPO2,BP | the variables were assessed for an interval of 30 minutes. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| adverse drug effects | the patients were closely observed for any drug induced adverse events. | 30 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omid Ahmadi, professor | Isfahan University of Medical Sciences | Study Director |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Morphine | Drug | morphine 0.05 mg/kg |
|
|
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |