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Burn Healing and Analgesia With Propranolol

Information source: University of North Carolina, Chapel Hill
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burns; Pain

Intervention: Propranolol (Drug); Placebo (Drug); Propanolol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Samuel McLean, MD, MPh, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill

Overall contact:
April J Soward, MPh, Phone: 1-866-939-0267, Email: BurnHelp@unc.edu

Summary

The purpose of this study is to determine whether propranolol can decrease pain symptoms in a common subset of patients admitted to a burn center after thermal burn.

Clinical Details

Official title: The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain (0-10 NRS Scales): Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.

Secondary outcome:

Sleep Quality using MOS Sleep Scale

Itch symptoms using 0-10 NRS scale

Anxiety Symptoms

Eligibility

Minimum age: 18 Years. Maximum age: 59 Years. Gender(s): Both.

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)

Locations and Contacts

April J Soward, MPh, Phone: 1-866-939-0267, Email: BurnHelp@unc.edu

North Carolina Jaycee Burn Center, Chapel Hill, North Carolina 27514, United States; Recruiting
Samuel A McLean, MD, MPh, Principal Investigator
Bruce A Cairns, MD, Sub-Investigator
Shrikant Bangdiwala, PhD, Sub-Investigator
Luda Diatchenko, MD, PhD, Sub-Investigator
Robert Maile, PhD, Sub-Investigator
Omar Halawa, MS, BS, Sub-Investigator
Janelle Hoskins, PhD, Sub-Investigator
Additional Information

NC Jaycee Burn Center

Starting date: July 2009
Last updated: November 2, 2009

Page last updated: October 04, 2010

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