Burn Healing and Analgesia With Propranolol (BURN HELP)

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: Burns; Pain

Treatments: Drug: Propanolol; Drug: Placebo; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT00934947

09-0681

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

Sugar pill

Placebo Comparator group

Treatment:

Drug: Placebo

Propranolol, Propanolol ER

Experimental group

Treatment:

Drug: Propranolol

Drug: Propanolol