Burn Healing and Analgesia With Propranolol (BURN HELP)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Burns
• Intervention / Treatment: Drug: Placebo; Drug: Propranolol; Drug: Propanolol

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20011
      • Washington Hospital Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • North Carolina Jaycee Burn Center
    • Wake Forest, North Carolina, United States, 27587
      • Wake Forest University Baptist
  • Pennsylvania
    • Upland, Pennsylvania, United States, 19102
      • Crozer Chester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Sugar pill	Drug: Placebo; sugar pill; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Pain Trajectory Slopes	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.	Study days 5, 7, 10, 13, 17 and 19

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	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.	6 weeks after injury timepoint was chosen for this analysis
Itch Symptoms	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.	Week 6 after injury was chosen as the main timepoint of interest
Anxiety Symptoms	Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.	6 weeks after injury was chosen as the main timepoint of interest

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Samuel McLean, MD, MPh, University of North Carolina, Department of Anesthesiology

Publications and helpful links

Helpful Links

• NC Jaycee Burn Center

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (ESTIMATE): July 8, 2009

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Pain; Burns
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: 09-0681