Burn Healing and Analgesia With Propranolol
- Registration Number
- NCT00934947
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Thermal burn
- Greater than or equal to 18 years of age
- Less than 60 years of age
- Able to speak and read English
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugar pill Placebo - Propranolol, Propanolol ER Propanolol - Propranolol, Propanolol ER Propranolol -
- Primary Outcome Measures
Name Time Method Overall Pain Trajectory Slopes Study days 5, 7, 10, 13, 17 and 19 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.
- Secondary Outcome Measures
Name Time Method Sleep Quality 6 weeks after injury timepoint was chosen for this analysis 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.
Itch Symptoms Week 6 after injury was chosen as the main timepoint of interest 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.
Anxiety Symptoms 6 weeks after injury was chosen as the main timepoint of interest Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.
Trial Locations
- Locations (4)
Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
North Carolina Jaycee Burn Center
🇺🇸Chapel Hill, North Carolina, United States
Crozer Chester Medical Center
🇺🇸Upland, Pennsylvania, United States
Wake Forest University Baptist
🇺🇸Wake Forest, North Carolina, United States