NCT00654329

Dexmedetomidine vs Fentanyl for BMT

Dexmedetomidine for Peri-operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Accepted

Summary

A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.

Conditions

• Otitis

Interventions

Type	Name	Description
DRUG	Saline	Normal saline, given intranasally
DRUG	Fentanyl	Fentanyl, nasal transmucosal, 2 micrograms/kilogram
DRUG	Dexmedetomidine	Dexmedetomidine, transmucosal, 1 microgram/kilogram
DRUG	Dexmedetomidine	Dexmedetomidine, 2 microgram/kilogram, transmucosal route

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-04-08
• Last updated: 2011-04-25
• Results posted: 2011-04-25

Locations

1 site across 1 country: United States