Burn Healing and Analgesia With Propranolol

Study Overview
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Brief Summary
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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.

Official Title
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The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol

Conditions
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Burns, Pain

Intervention / Treatment
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* Drug: Propranolol
* Drug: Placebo
* Drug: Propanolol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar pill<br> | Drug: Placebo<br>* sugar pill<br>* Other names: Sugar pill;|
| Experimental: Propranolol, Propanolol ER<br> | Drug: Propranolol<br>* 40 mg<br>* Other names: Innopran;Drug: Propanolol<br>* 120 mg twice per day<br>* Other names: Innopran;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Pain