drugset / Trial / NCT04266340

Different Premedication in Pediatric Patients

NCT04266340

RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2020-12-13
Primary completion
2021-11-15
Completion
2021-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 2.5 ug/kg Intranasal
Subject Midazolam Small molecule 0.03 mg/kg Oral
Subject Midazolam Small molecule 0.05 mg/kg Oral
Subject Midazolam Small molecule 0.5 mg/kg Oral

Indications

No indication recorded.