NCT00778063

Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients

Intranasal Dexmedetomidine Decreases Emergence Delirium in Pediatric Patients After Sevoflurane Based General Anesthesia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium during general sevoflurane anesthesia in a pediatric population receiving pressure equalization tubes in one or more ear.

Detailed description

Emergence delirium has been described as a dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent, inconsolably crying, moaning, kicking or thrashing. The children can run the gambit from restlessness and incoherence to combative and psychotic. The incidence of emergence agitation or delirium is 80% after a procedure with sevoflurane-induced anesthesia. Dexmedetomidine has been shown to have sedative and analgesic effects. In the pediatric population, it has been shown to provide sedation for radiographic procedures. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intranasally might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing myringotomy and tube placement.

Conditions

• Otitis Media

Interventions

Type	Name	Description
DRUG	dexmedetomidine	2 mcg/kg intranasally 30 minutes prior to surgery
DRUG	saline	a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2008-10-23
• Last updated: 2023-04-13

Locations

1 site across 1 country: United States