Burn Healing and Analgesia With Propranolol (BURN HELP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00934947
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : October 29, 2012
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

July 6, 2009
July 8, 2009
May 7, 2012
October 29, 2012
November 17, 2017
July 2009
February 2011   (Final data collection date for primary outcome measure)
Overall Pain Trajectory Slopes [ Time Frame: Study days 5, 7, 10, 13, 17 and 19 ]
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.
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 ]
Complete list of historical versions of study NCT00934947 on Archive Site
  • Sleep Quality [ Time Frame: 6 weeks after injury timepoint was chosen for this analysis ]
    Medical Outcomes Survey Sleep Quality Subscale. This is a 0-10 numeric rating scale in which patients rate their sleep quality. 0 represents poor sleep quality whereas 10 represents a restful night of sleep.
  • Itch Symptoms [ Time Frame: Week 6 after injury was chosen as the main timepoint of interest ]
    Average itch intensity measured with a 0-10 numeric rating scale, 6 weeks was used as main outcome timepoint for itch symptom burden. 0 represents no itch symptoms and 10 represents the most severe itch symptoms.
  • Anxiety Symptoms [ Time Frame: 6 weeks after injury was chosen as the main timepoint of interest ]
    Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.
  • Sleep Quality using MOS Sleep Scale [ Time Frame: Study days 5, 7, 10, 13, 17, and 19 ]
  • Itch symptoms using 0-10 NRS scale [ Time Frame: Study days 5, 7, 10, 13, 17, and 19 ]
  • Anxiety Symptoms [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ]
Not Provided
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Burn Healing and Analgesia With Propranolol
The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Burns
  • Pain
  • Drug: Propranolol
    40 mg
    Other Names:
    • Inderal
    • Innopran
  • Drug: Placebo
    sugar pill
    Other Name: Sugar pill
  • Drug: Propanolol
    120 mg twice per day
    Other Names:
    • Inderal
    • Innopran
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Placebo
  • Experimental: Propranolol, Propanolol ER
    • Drug: Propranolol
    • Drug: Propanolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
February 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Samuel McLean, MD, MPh University of North Carolina, Department of Anesthesiology
University of North Carolina, Chapel Hill
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP