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To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Experimental | midazolam 3～5μg/kg•min for maintenance of sedation. |
|
| Dexmedetomidine1 | Experimental | Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； |
|
| Dexmedetomidine2 | Experimental | Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； |
|
| Dexmedetomiding3 | Experimental | Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | midazolam 3～5μg/kg•min for maintenance of sedation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of time at target sedation score | assess the sedation level every 2 min using Ramsay score | up to 24 hours |
| the number of patients requiring the sedation remedy | the number of patients requiring the sedation remedy during the mechanical ventilation | up to 24 hours |
| the dosage of midazolam that need for the sedation remedy | the dosage of midazolam that need for sedation remedy during the mechanical ventilation | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| change of blood pressure | the change of blood pressure at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used. | up to 24 hours. |
| change of heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Dexmedetomidine | Drug | Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； |
|
|
| Dexmedetomidine | Drug | Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation； |
|
|
| Dexmedetomidine | Drug | Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation； |
|
|
| Fentanyl | Drug | Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia |
|
|
| assessment | Other | Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment. |
|
the change of heart rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used.
| up to 24 hours |
| change of respiratory rate | the change of respiratory rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used. | up to 24 hours |
| change of blood oxygen saturation | the change of blood oxygen saturation at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used. | up to 24 hours |
| extubation time | time from beginning of study drug used to extubation | up to 24 hours |
| change of hepatic function | change of blood ALT、AST level at baseline and 24 hours after the sedation drug used. | up to 24 hours |
| change of renal function | change of blood Cr、BUN level at baseline and 24 hours after the sedation drug used. | up to 24 hours |
| the dosage of sedation and analgesia drug | the total dosage of sedation and analgesia drug during the sedation and analgesia period | up to 24 hours |
| the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used | up to 24 hours |
| the dosage of fentanyl in and after 6 hours from study drug used | up to 24 hours |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010880 | Piperidines |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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