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The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group.
Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium [PAED] scale) and POV were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU and patients' satisfaction degree were also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | no premedication |
|
| oralmidazolam | Experimental | 0.5 mg/kg oral midazolam group |
|
| intravenous midazolam | Experimental | 0.05 mg/kg intravenous injection midazolam group |
|
| dexmedetomidine | Experimental | 2.5µg/kg intranasal dexmedetomidine group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine | Drug | 2.5µg/kg intranasal dexmedetomidine group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation |
| 10 minutes after premedication |
| Sedation |
| 20 minutes after premedication |
| Sedation |
| 30 minutes after premedication |
| Emotional state |
| 0 minutes after they were separated from their parents |
| Emotional state |
| 0 minutes after intravenous cannulation |
| Emotional state |
| 0 minutes after facemask application |
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Inclusion Criteria:
-
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36506775 | Derived | Qiao H, Chen J, Lv P, Ye Z, Lu Y, Li W, Jia J. Efficacy of premedication with intravenous midazolam on preoperative anxiety and mask compliance in pediatric patients: a randomized controlled trial. Transl Pediatr. 2022 Nov;11(11):1751-1758. doi: 10.21037/tp-22-161. |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| midazolam |
| Drug |
0.5mg/kg oral midazolam |
|
| midazolam | Drug | 0.05mg/kg intravenous injection midazolam |
|
| Saline | Drug | no premedication |
|
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |