Burn Healing and Analgesia With Propranolol - Full Text View

Sponsor:	University of North Carolina, Chapel Hill
Information provided by (Responsible Party):	Samuel McLean, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00934947

Purpose

The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype.

Condition	Intervention	Phase
Burns Pain	Drug: Propranolol Drug: Placebo Drug: Propanolol	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Burns

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Pain Symptoms [ Time Frame: Study days 5, 7, 10, 13, 17 and 19 ] [ Designated as safety issue: No ]
Daily average pain score (0-10 numerical rating pain score recorded daily via self-report) after study drug initiation

Secondary Outcome Measures:

Sleep Quality [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ] [ Designated as safety issue: No ]
Itch symptoms [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ] [ Designated as safety issue: No ]
Anxiety Symptoms [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2009
Study Completion Date:	June 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Sugar pill	Drug: Placebo sugar pill Other Names: Sugar pill Placebo
Experimental: Propranolol, Propanolol ER	Drug: Propranolol 40 mg Other Names: Inderal Innopran Drug: Propanolol 120 mg twice per day Other Names: Inderal Innopran

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Thermal burn
Greater than or equal to 18 years of age
Less than 60 years of age
Able to speak and read English

Exclusion Criteria:

Intubated
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934947

Locations

United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20011
United States, North Carolina
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, United States, 27514
Wake Forest University Baptist
Wake Forest, North Carolina, United States, 27587
United States, Pennsylvania
Crozer Chester Medical Center
Upland, Pennsylvania, United States, 19102

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Samuel McLean, MD, MPh

University of North Carolina, Department of Anesthesiology

More Information

Additional Information:

NC Jaycee Burn Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Samuel McLean, MD, Principle Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00934947 History of Changes
Other Study ID Numbers:	09-0681
Study First Received:	July 6, 2009
Last Updated:	September 26, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

Burns
Pain

Additional relevant MeSH terms:

Burns
Wounds and Injuries
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents

Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012