Burn Healing and Analgesia With Propranolol
Information source: The University of North Carolina, Chapel Hill
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burns; Pain
Intervention: Propranolol (Drug); Sugar pill (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: The University of North Carolina, Chapel Hill Overall contact:
April J Soward, MPh, Phone: 1-866-939-0267, Email: BurnHelp@unc.edu
Summary
The purpose of this study is to determine whether propranolol can decrease pain symptoms in
a common subset of patients admitted to a burn center after thermal burn.
Clinical Details
Official title: The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Pain (0-10 NRS Scales): Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.
Secondary outcome: Sleep Quality using MOS Sleep ScaleItch symptoms using 0-10 NRS scale 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
April J Soward, MPh, Phone: 1-866-939-0267, Email: BurnHelp@unc.edu
North Carolina Jaycee Burn Center, Chapel Hill, North Carolina 27514, United States
Additional Information
NC Jaycee Burn Center
Starting date: July 2009
Ending date: July 2011
Last updated: July 7, 2009
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