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Sponsors and Collaborators: |
Children's Research Institute Hospira, Inc. |
Information provided by: | Children's Research Institute |
ClinicalTrials.gov Identifier: | NCT00654329 |
Relative to placebo or fentanyl,
Condition | Intervention | Phase |
To Perform a Dose Ranging Study of Nasal Transmucosal Dexmedetomidine |
Drug: Saline Drug: Fentanyl Drug: Dexmedetomidine |
Phase IV |
ChemIDplus related topics: | Fentanyl Citrate Fentanyl Sodium chloride Dexmedetomidine Dexmedetomidine hydrochloride Salicylsalicylic acid Sodium salicylate |
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 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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:
The subject's parent/legally authorized guardian has given written informed consent to participate
Exclusion Criteria:
Subjects will be excluded from study participation if any of the following exclusion criteria exists:
Contact: Julia C Finkel, MD | 202-476-4867 ext 4867 | jfinkel@cnmc.org |
Contact: Kavita K Nair, MPH | 202-476-2316 ext 2316 | knair@cnmc.org |
United States, District of Columbia | |||||
Children's National Medical Center | Recruiting | ||||
Washington, District of Columbia, United States, 20010 | |||||
Contact: Julia C Finkel, MD jfinkel@cnmc.org | |||||
Principal Investigator: Julia C Finkel, MD |
Children's Research Institute |
Hospira, Inc. |
Principal Investigator: | Julia C Finkel, MD | Childrens Research Institute |
Responsible Party: | Children's National Medical Center ( Julia C. Finkel, MD ) |
Study ID Numbers: | 3641, Agreement # 10698 |
First Received: | April 3, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00654329 |
Health Authority: | United States: Institutional Review Board |
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