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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:


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:
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