Status:
TERMINATED
Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients
Lead Sponsor:
Ochsner Health System
Conditions:
Otitis Media
Eligibility:
All Genders
1-5 years
Phase:
NA
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 p...
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 thras...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00778063
Start Date
September 1 2008
End Date
March 1 2013
Last Update
April 13 2023
Active Locations (1)
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1
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121