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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01188551 |
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Date of registration:
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24/08/2010 |
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Primary sponsor: |
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Public title:
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Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement
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Scientific title:
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Pain Management Following Myringotomy and Tube Placement: Intranasal Dexmedetomidine Versus Fentanyl |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01188551 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- functional status as assigned by the American Society of Anesthesiology (ASA)
classification of I or II (no or minimal co-morbid disease)
- patients scheduled for placement of bilateral myringotomy tubes
Exclusion Criteria:
- history of allergy to either dexmedetomidine or fentanyl
- concomitant use of medications which may exaggerate the HR response of
dexmedetomidine including digoxin or ß-adrenergic antagonists.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Otitis Media
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Intervention(s)
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Drug: Dexmedetomidine
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Drug: Fentanyl
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Primary Outcome(s)
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Pain
[Time Frame: 60 mins. post-op]
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Secondary Outcome(s)
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Recovery characteristics from general anesthesia
[Time Frame: 60 mins. post-op]
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Secondary ID(s)
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IRB10-00377
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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