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Burn Healing and Analgesia With Propranolol (BURN HELP)

Primary Purpose

Burns, Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Placebo
Propanolol
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns, Pain

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • Washington Hospital Center
  • North Carolina Jaycee Burn Center
  • Wake Forest University Baptist
  • Crozer Chester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sugar pill

Propranolol, Propanolol ER

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Anxiety Symptoms
Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.

Full Information

First Posted
July 6, 2009
Last Updated
October 16, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT00934947
Brief Title
Burn Healing and Analgesia With Propranolol
Acronym
BURN HELP
Official Title
The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Pain
Keywords
Burns, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Title
Propranolol, Propanolol ER
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Inderal, Innopran
Intervention Description
40 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
Propanolol
Other Intervention Name(s)
Inderal, Innopran
Intervention Description
120 mg twice per day
Primary Outcome Measure Information:
Title
Overall Pain Trajectory Slopes
Description
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.
Time Frame
Study days 5, 7, 10, 13, 17 and 19
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
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.
Time Frame
6 weeks after injury timepoint was chosen for this analysis
Title
Itch Symptoms
Description
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.
Time Frame
Week 6 after injury was chosen as the main timepoint of interest
Title
Anxiety Symptoms
Description
Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.
Time Frame
6 weeks after injury was chosen as the main timepoint of interest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel McLean, MD, MPh
Organizational Affiliation
University of North Carolina, Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
North Carolina Jaycee Burn Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Wake Forest University Baptist
City
Wake Forest
State/Province
North Carolina
ZIP/Postal Code
27587
Country
United States
Facility Name
Crozer Chester Medical Center
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.med.unc.edu/burn
Description
NC Jaycee Burn Center

Learn more about this trial

Burn Healing and Analgesia With Propranolol

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