Otitis Media
Conditions
Keywords
dexmedetomidine, pressure equalization tubes in the ear, myringotomy, sevoflurane
Brief 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.
Interventions
DRUGdexmedetomidine
2 mcg/kg intranasally 30 minutes prior to surgery
DRUGsaline
a volume of intranasal saline, calculated based on body weight, will be given 30 minutes prior to surgery
Sponsors
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA class 1 or 2 (healthy patient or acute illness) * Parental willingness to participate * Candidate for pressure-equalization tubes (PET) as determined by the ENT department
Exclusion criteria
* ASA class 3 or 4 (chronic illness or life-threatening illness) * Parental refusal to participate * Significant liver disease by history * Allergy to dexmedetomidine or midazolam * Nasal deformity * Fever in the three days prior to surgery * Nausea or vomiting * History of hypertension * History of cardiac dysfunction/disorder * Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia. | 2 hours post-surgery |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate post-operative pain, emesis, and time to release from recovery. | 2 hours post-surgery |
Countries
United States
Outcome results
None listed