An interventional study of dexmedetomidine and saline in Otitis Media, sponsored by Ochsner Health System. Terminated at 1 site in United States. Open to participants aged 1 Year to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Ochsner Health System · Not applicable, Interventional, and Prevention
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.
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.
284 studies on the registry are indexed under Otitis Media; 33 are open to participants now.
This study's enrollment of 40 is below the median of 126 across 194 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Ochsner Health System is the lead sponsor of 54 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
intranasal saline will be given 30 minutes prior to surgery
Drug: saline
2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery
Drug: dexmedetomidine
2 mcg/kg intranasally 30 minutes prior to surgery
Also known as: Precedex
a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery
To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia.
Time frame: 2 hours post-surgery
Evaluate post-operative pain, emesis, and time to release from recovery.
Time frame: 2 hours post-surgery
This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Ochsner Health System