Dexmedetomidine vs Fentanyl for BMT
NCT00654329 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2011-04-25
Summary
A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.
Conditions
- Otitis
Interventions
- DRUG
-
Saline
Normal saline, given intranasally
- DRUG
-
Fentanyl, nasal transmucosal, 2 micrograms/kilogram
- DRUG
-
Dexmedetomidine
Dexmedetomidine, transmucosal, 1 microgram/kilogram
- DRUG
-
Dexmedetomidine
Dexmedetomidine, 2 microgram/kilogram, transmucosal route
Sponsors & Collaborators
-
Hospira, now a wholly owned subsidiary of Pfizer
collaborator INDUSTRY -
Children's National Research Institute
lead OTHER
Principal Investigators
-
Julia C Finkel, MD · Children's National Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-08-31
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
Countries
- United States
Study Locations
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