Burn Healing and Analgesia With Propranolol

Pain Clinical Trial

— BURN HELP  

Official title:

The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934947
• Other study ID #: 09-0681
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2009
• Last updated: October 16, 2017
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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)

Related Conditions & MeSH terms

• Burns
• Pain

Intervention

Drug:
• Propranolol
40 mg
• Placebo
sugar pill
• Propanolol
120 mg twice per day

Locations

Country	Name	City	State
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	Washington Hospital Center	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   NC Jaycee Burn Center