Burn Healing and Analgesia With Propranolol

NCT ID: NCT00934947

Last Updated: 2017-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Burns Pain

Keywords

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Burns Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sugar pill

Propranolol, Propanolol ER

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

40 mg

Propanolol

Intervention Type DRUG

120 mg twice per day

Interventions

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Propranolol

40 mg

Intervention Type DRUG

Placebo

sugar pill

Intervention Type DRUG

Propanolol

120 mg twice per day

Intervention Type DRUG

Other Intervention Names

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Inderal Innopran Sugar pill Inderal Innopran

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel McLean, MD, MPh

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Department of Anesthesiology

Locations

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Washington Hospital Center

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

Site Status

North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, United States

Site Status

Wake Forest University Baptist

Wake Forest, North Carolina, United States

Site Status

Crozer Chester Medical Center

Upland, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.med.unc.edu/burn

NC Jaycee Burn Center

Other Identifiers

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09-0681

Identifier Type: -

Identifier Source: org_study_id