NCT03171740

Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children

Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children: Superiority Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Brasilia University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.

Detailed description

Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.

Conditions

• Emergence Delirium

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)
DRUG	Midazolam oral solution	Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)
DRUG	Oral saline	Oral saline, 0.25ml/kg
DRUG	Nasal saline	Nasal saline 0.01ml/kg

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-12-01
• Completion: 2018-01-15
• First posted: 2017-05-31
• Last updated: 2018-07-13

Locations

1 site across 1 country: Brazil