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Burn Healing and Analgesia With Propranolol (BURN HELP)

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ClinicalTrials.gov Identifier: NCT00934947
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : October 29, 2012
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Burns Pain Drug: Propranolol Drug: Placebo Drug: Propanolol Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
Study Start Date : July 2009
Primary Completion Date : February 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Sugar pill Drug: Placebo
sugar pill
Other Name: Sugar pill
Experimental: Propranolol, Propanolol ER Drug: Propranolol
40 mg
Other Names:
  • Inderal
  • Innopran
Drug: Propanolol
120 mg twice per day
Other Names:
  • Inderal
  • Innopran


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934947


Locations
United States, District of Columbia
Washington Hospital Center
Washington, D.C., 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:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00934947     History of Changes
Other Study ID Numbers: 09-0681
First Posted: July 8, 2009    Key Record Dates
Results First Posted: October 29, 2012
Last Update Posted: November 17, 2017
Last Verified: September 2017

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
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents