Burn Healing and Analgesia With Propranolol (BURN HELP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel McLean, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00934947
First received: July 6, 2009
Last updated: September 25, 2012
Last verified: September 2012
  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 2

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:


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

Primary Outcome Measures:
  • Overall Pain Trajectory Slopes [ Time Frame: Study days 5, 7, 10, 13, 17 and 19 ] [ Designated as safety issue: No ]
    Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.


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 ]

Enrollment: 45
Study Start Date: July 2009
Study Completion Date: June 2011
Primary Completion Date: February 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Results First Received: May 7, 2012
Last Updated: September 25, 2012
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
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 21, 2014