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Burn Healing and Analgesia With Propranolol

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burns; Pain

Intervention: Propranolol (Drug); Placebo (Drug); Propanolol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Samuel McLean, MD, MPh, Principal Investigator, Affiliation: University of North Carolina, Department of Anesthesiology

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall Pain Trajectory Slopes

Secondary outcome:

Sleep Quality

Itch Symptoms

Anxiety Symptoms

Eligibility

Minimum age: 18 Years. Maximum age: 59 Years. Gender(s): Both.

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)

Locations and Contacts

Washington Hospital Center, Washington, District of Columbia 20011, United States

North Carolina Jaycee Burn Center, Chapel Hill, North Carolina 27514, United States

Wake Forest University Baptist, Wake Forest, North Carolina 27587, United States

Crozer Chester Medical Center, Upland, Pennsylvania 19102, United States

Additional Information

NC Jaycee Burn Center

Starting date: July 2009
Last updated: October 7, 2014

Page last updated: August 23, 2015

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