Burn Healing and Analgesia With Propranolol - Full Text View

Burn Healing and Analgesia With Propranolol (BURN HELP)

This study is currently recruiting participants.

Verified by The University of North Carolina, Chapel Hill, November 2009

First Received: July 6, 2009 Last Updated: November 2, 2009 History of Changes

Sponsor:	The University of North Carolina, Chapel Hill
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00934947

Purpose

The purpose of this study is to determine whether propranolol can decrease pain symptoms in a common subset of patients admitted to a burn center after thermal burn.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol

Resource links provided by NLM:

MedlinePlus related topics: Burns

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

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

Primary Outcome Measures:

Pain (0-10 NRS Scales): Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation. [ Time Frame: Study days 5, 7, 10, 13, 17 and 19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sleep Quality using MOS Sleep Scale [ Time Frame: Study days 5, 7, 10, 13, 17, and 19 ] [ Designated as safety issue: No ]
Itch symptoms using 0-10 NRS scale [ Time Frame: Study days 5, 7, 10, 13, 17, and 19 ] [ Designated as safety issue: No ]
Anxiety Symptoms [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study month 3 and 6 ] [ Designated as safety issue: No ]

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

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

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

Contacts

Contact: April J Soward, MPh

1-866-939-0267

BurnHelp@unc.edu

Locations

United States, North Carolina
North Carolina Jaycee Burn Center	Recruiting
Chapel Hill, North Carolina, United States, 27514
Principal Investigator: Samuel A McLean, MD, MPh
Sub-Investigator: Bruce A Cairns, MD
Sub-Investigator: Shrikant Bangdiwala, PhD
Sub-Investigator: Luda Diatchenko, MD, PhD
Sub-Investigator: Robert Maile, PhD
Sub-Investigator: Omar Halawa, MS, BS
Sub-Investigator: Janelle Hoskins, PhD

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Samuel McLean, MD, MPh

The University of North Carolina, Chapel Hill

More Information

Additional Information:

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

No publications provided

Responsible Party:	University of North Carolina ( Samuel McLean, MD, MPh )
Study ID Numbers:	09-0681
Study First Received:	July 6, 2009
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00934947 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

Burns
Pain

Additional relevant MeSH terms:

Burns
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Propranolol
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 08, 2010