Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2009-07-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sugar pill
Placebo
sugar pill
Propranolol, Propanolol ER
Propranolol
40 mg
Propanolol
120 mg twice per day
Interventions
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Propranolol
40 mg
Placebo
sugar pill
Propanolol
120 mg twice per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Greater than or equal to 18 years of age
* Less than 60 years of age
* Able to speak and read English
Exclusion Criteria
* Clinically unstable
* Other substantial comorbid injury (e.g. long bone fracture)
* Heart block greater than first degree (EKG)
* History of coronary artery disease
* History of congestive heart failure
* Asthma (within past 10 years, induced by a beta-blocker, or receiving current treatment)
* Pregnant
* Prisoner
* Psychotic, suicidal, or homicidal
* Diabetic
* Hepatic failure (acute or chronic)
* Renal failure (acute or chronic)
* History of hyperthyroidism unless taking synthroid or other thyroid hormone replacement
* Exceeds daily acceptable chronic opioid use prior to burn
* Interacting medication
* Received propranolol within the last 6 months
* Multiple severe allergic reactions
* On daily methylphenidate or similar stimulant medication
* Unwilling to use medically acceptable birth control (if childbearing potential)
* Breastfeeding
* Severe peripheral vascular disease or vasospastic disorder
* Bradycardia that in the opinion of the investigator would constitute too great a risk when considered in the context of the patient's medical comorbidities and health history
* Other criteria that in investigator's opinion makes participant poor candidate for the trial
* Cancer (except basal cell cancer)
18 Years
59 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Samuel McLean, MD, MPh
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Department of Anesthesiology
Locations
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Washington Hospital Center
Washington D.C., District of Columbia, United States
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, United States
Wake Forest University Baptist
Wake Forest, North Carolina, United States
Crozer Chester Medical Center
Upland, Pennsylvania, United States
Countries
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Related Links
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NC Jaycee Burn Center
Other Identifiers
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09-0681
Identifier Type: -
Identifier Source: org_study_id