NCT04266340

Different Premedication in Pediatric Patients

Effects of Different Premedication on Preoperative Sedation and Postoperative Agitation in Children Undergoing Ophthalmic and Otorhinolaryngologic Operations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Agitation

Interventions

Type	Name	Description
DRUG	dexmedetomidine	2.5µg/kg intranasal dexmedetomidine group
DRUG	midazolam	0.5mg/kg oral midazolam
DRUG	midazolam	0.05mg/kg intravenous injection midazolam
DRUG	Saline	no premedication

Timeline

• Start date: 2020-12-13
• Primary completion: 2021-11-15
• Completion: 2021-12-01
• First posted: 2020-02-12
• Last updated: 2022-05-11

Locations

1 site across 1 country: China