Burn Healing and Analgesia With Propranolol

NCT00934947 | Completed Phase 2 Results DMC

• 1 other identifier: 09-0681
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

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.

Conditions

Burns; Pain

Keywords

Burns; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Study days 5, 7, 10, 13, 17 and 19

Secondary Outcomes (3)

• Sleep Quality

  6 weeks after injury timepoint was chosen for this analysis

• Itch Symptoms

  Week 6 after injury was chosen as the main timepoint of interest

• Anxiety Symptoms

  6 weeks after injury was chosen as the main timepoint of interest

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Propranolol, Propanolol ER

EXPERIMENTAL

Drug: Propranolol; Drug: Propanolol

Interventions

Propranolol DRUG

40 mg

Also known as: Inderal, Innopran

Propranolol, Propanolol ER

Placebo DRUG

sugar pill

Also known as: Sugar pill

Sugar pill

Propanolol DRUG

120 mg twice per day

Also known as: Inderal, Innopran

Propranolol, Propanolol ER

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Thermal burn
• Greater than or equal to 18 years of age
• Less than 60 years of age
• Able to speak and read English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (4)

Washington Hospital Center

Washington D.C., District of Columbia, 20011, United States

Location

North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, 27514, United States

Location

Wake Forest University Baptist

Wake Forest, North Carolina, 27587, United States

Location

Crozer Chester Medical Center

Upland, Pennsylvania, 19102, United States

Location

Related Links

• NC Jaycee Burn Center

MeSH Terms

Conditions

Burns; Pain

Interventions

Propranolol; Sugars

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Samuel McLean
• Organization: UNC Department of Anesthesiology

smclean@aims.unc.edu

919-966-7315

Study Officials

• Samuel McLean, MD, MPh

  University of North Carolina, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 17, 2017
• Results First Posted: October 29, 2012

Record last verified: 2017-09

Locations

US (4)