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Completed

NCT Number: NCT00934947

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.

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Key information

Conditions

Burns Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington Hospital Center, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Propranolol

Drug

40 mg

Other names: Inderal, Innopran

Placebo

Drug

sugar pill

Other names: Sugar pill

Propanolol

Drug

120 mg twice per day

Other names: Inderal, Innopran

Primary outcomes

  1. Overall Pain Trajectory Slopes

    Time frame: 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 outcomes

  1. Sleep Quality

    Time frame: 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.

  2. Itch Symptoms

    Time frame: 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.

  3. Anxiety Symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol

Acronym: BURN HELP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2009
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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