Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2020-12-13
2021-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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placebo
no premedication
Saline
no premedication
oralmidazolam
0.5 mg/kg oral midazolam group
midazolam
0.5mg/kg oral midazolam
intravenous midazolam
0.05 mg/kg intravenous injection midazolam group
midazolam
0.05mg/kg intravenous injection midazolam
dexmedetomidine
2.5µg/kg intranasal dexmedetomidine group
dexmedetomidine
2.5µg/kg intranasal dexmedetomidine group
Interventions
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dexmedetomidine
2.5µg/kg intranasal dexmedetomidine group
midazolam
0.5mg/kg oral midazolam
midazolam
0.05mg/kg intravenous injection midazolam
Saline
no premedication
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
12 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Locations
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Department of Anesthesiology, The Eye, Ear, Nose and Throat Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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20180341
Identifier Type: -
Identifier Source: org_study_id
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