Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
101 participants
INTERVENTIONAL
2005-08-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dexmedetomidine 1microgram/kilogram
Dexmedetomidine 1microgram/kilogram intranasal
Dexmedetomidine
Dexmedetomidine, transmucosal, 1 microgram/kilogram
Dexmedetomidine 2 micrograms/kilogram
Dexmedetomidine 2 micrograms/kilogram intranasal
Dexmedetomidine
Dexmedetomidine, 2 microgram/kilogram, transmucosal route
Fentanyl 2 micrograms/kilogram
Fentanyl 2 micrograms/kilogram intranasal
Fentanyl
Fentanyl, nasal transmucosal, 2 micrograms/kilogram
Normal saline placebo
Normal saline placebo intranasal
Saline
Normal saline, given intranasally
Interventions
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Saline
Normal saline, given intranasally
Fentanyl
Fentanyl, nasal transmucosal, 2 micrograms/kilogram
Dexmedetomidine
Dexmedetomidine, transmucosal, 1 microgram/kilogram
Dexmedetomidine
Dexmedetomidine, 2 microgram/kilogram, transmucosal route
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject's American Society of Anesthesiologists (ASA) physical status is ASA 1 or 2 (see appendix 1)
3. The subject is scheduled for elective bilateral myringotomy with tube placement
4. The subject's parent/legally authorized guardian has given written informed consent to participate
Exclusion Criteria
2. The subject has known significant renal or hepatic disorders determined by medical history, physical examination or laboratory tests
3. The subject has a known or suspected allergy to opioid analgesics or dexmedetomidine
4. The subject has history of. cardiovascular issues which would preclude the use of dexmedetomidine, (e.g. Down's Syndrome, dysrhythmias, conditions where hypotension is to be avoided)
5. The subject has know central nervous system disease or neurological impairment
6. The subject is an ASA classification of 3 or greater (See Appendix 1)
7. The subject has a medical condition requiring an intravenous induction (i.e. severe uncontrolled gastro-esophageal reflux)
8. The subject refuses inhalation induction
9. The subject is scheduled for a surgical sub-procedure (i.e. adenoidectomy, tonsillectomy)
6 Months
6 Years
ALL
Yes
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Children's National Research Institute
OTHER
Responsible Party
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Children's National Medical Center
Principal Investigators
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Julia C Finkel, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
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Children's National Medical Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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Agreement # 10698
Identifier Type: -
Identifier Source: secondary_id
3641
Identifier Type: -
Identifier Source: org_study_id
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