Burn Healing and Analgesia With Propranolol (BURN HELP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samuel McLean, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00934947
First received: July 6, 2009
Last updated: October 7, 2014
Last verified: October 2014

July 6, 2009
October 7, 2014
July 2009
February 2011   (final data collection date for primary outcome measure)
Overall Pain Trajectory Slopes [ Time Frame: Study days 5, 7, 10, 13, 17 and 19 ] [ Designated as safety issue: No ]
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.
Pain (0-10 NRS Scales): Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation. [ Time Frame: Study days 5, 7, 10, 13, 17 and 19 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00934947 on ClinicalTrials.gov Archive Site
  • Sleep Quality [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ] [ Designated as safety issue: No ]
  • Itch Symptoms [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ] [ Designated as safety issue: No ]
  • Anxiety Symptoms [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study months 3 and 6 ] [ Designated as safety issue: No ]
  • Sleep Quality using MOS Sleep Scale [ Time Frame: Study days 5, 7, 10, 13, 17, and 19 ] [ Designated as safety issue: No ]
  • Itch symptoms using 0-10 NRS scale [ Time Frame: Study days 5, 7, 10, 13, 17, and 19 ] [ Designated as safety issue: No ]
  • Anxiety Symptoms [ Time Frame: Study days 5, 7, 10, 13, 17, and 19, study week 6, study month 3 and 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Burn Healing and Analgesia With Propranolol
The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Burns
  • Pain
  • Drug: Propranolol
    40 mg
    Other Names:
    • Inderal
    • Innopran
  • Drug: Placebo
    sugar pill
    Other Names:
    • Sugar pill
    • Placebo
  • Drug: Propanolol
    120 mg twice per day
    Other Names:
    • Inderal
    • Innopran
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Placebo
  • Experimental: Propranolol, Propanolol ER
    Interventions:
    • Drug: Propranolol
    • Drug: Propanolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
June 2011
February 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00934947
09-0681
Yes
Samuel McLean, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Samuel McLean, MD, MPh University of North Carolina, Department of Anesthesiology
University of North Carolina, Chapel Hill
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP