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Sponsors and Collaborators: |
Children's Research Institute Hospira, Inc. |
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Information provided by: | Children's Research Institute |
ClinicalTrials.gov Identifier: | NCT00654329 |
Relative to placebo or fentanyl,
Condition | Intervention | Phase |
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To Perform a Dose Ranging Study of Nasal Transmucosal Dexmedetomidine |
Drug: Saline Drug: Fentanyl Drug: Dexmedetomidine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Dexmedetomidine for Peri-Operative Sedation and Analgesia in Children Undergoing Bilateral Myringotomy With Tube Placement (BMT) |
Estimated Enrollment: | 160 |
Study Start Date: | August 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Saline
Normal saline, given intranasally
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2: Active Comparator |
Drug: Fentanyl
Fentanyl, nasal transmucosal, 2mcg/kg
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3: Experimental |
Drug: Dexmedetomidine
Dexmedetomidine, transmucosal, 1mcg/kg
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4: Experimental |
Drug: Dexmedetomidine
Dexmedetomidine, 2mcg/kg, transmucosal route
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Ages Eligible for Study: | 6 Months to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for participation:
Exclusion Criteria:
Subjects will be excluded from study participation if any of the following exclusion criteria exists:
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)
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010 |
Principal Investigator: | Julia C Finkel, MD | Children's Research Institute |
Responsible Party: | Children's National Medical Center ( Julia C. Finkel, MD ) |
Study ID Numbers: | 3641, Agreement # 10698 |
Study First Received: | April 3, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00654329 History of Changes |
Health Authority: | United States: Institutional Review Board |
Dexmedetomidine, transmucosal, myringotomy, |
Anesthetics, Intravenous Neurotransmitter Agents Fentanyl Adrenergic alpha-Agonists Adrenergic Agents Adjuvants, Immunologic Anesthetics Central Nervous System Depressants Narcotics |
Adrenergic Agonists Anesthetics, General Analgesics, Non-Narcotic Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Analgesics, Opioid |
Anesthetics, Intravenous Neurotransmitter Agents Fentanyl Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Adrenergic Agonists Pharmacologic Actions |
Adjuvants, Anesthesia Analgesics, Non-Narcotic Anesthetics, General Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |