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The study was not approved by Hospital's Medical Ethics Committee.
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The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.
Emergence delirium is a common side effect of sevoflurane anesthesia in children. Dexmedetomidine, because of its sedative and analgesic properties, might be useful for the management of this adverse effect. In the pediatric population, it has been shown to provide sedation for magnetic resonance imaging. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intravenously might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing oral maxillofacial surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Experimental | intravenously injecting 0.125microgram/kg and 0.25microgram/kg within 10 minutes as soon as the operation begins respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | Intravenously injecting 0.125microgram/kg for 10ml IV(in the vein)in group 1, 0.25microgram/kg for 10ml in group 2 within 10 minutes as soon as the operation begin. The control group receives 10mlsaline in 10 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| post anesthesia emergence delirium scale(PAED scale) | evaluate children's PAED scale score 2 hours post-surgery | 2 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale) | evaluate children's CHEOP scale score 2 hours post-surgery | 2 hours post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Jiang, MD, PHD | Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine | Study Director |
| Rong Hu, MD | Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine | Shanghai | Shanghai Municipality | 200011 | China |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |