Burn Healing and Analgesia With Propranolol (BURN HELP)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
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: September 25, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Burns Pain |
Drug: Propranolol Drug: Placebo Drug: Propanolol |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 45 |
| Study Start Date: | July 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Sugar pill |
Drug: Placebo
sugar pill
Other Names:
|
| Experimental: Propranolol, Propanolol ER |
Drug: Propranolol
40 mg
Other Names:
Drug: Propanolol
120 mg twice per day
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934947
Locations
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20011 | |
| United States, North Carolina | |
| North Carolina Jaycee Burn Center | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Wake Forest University Baptist | |
| Wake Forest, North Carolina, United States, 27587 | |
| United States, Pennsylvania | |
| Crozer Chester Medical Center | |
| Upland, Pennsylvania, United States, 19102 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | Samuel McLean, MD, MPh | University of North Carolina, Department of Anesthesiology |
More Information
Additional Information:
No publications provided
| Responsible Party: | Samuel McLean, MD, Principle Investigator, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00934947 History of Changes |
| Other Study ID Numbers: | 09-0681 |
| Study First Received: | July 6, 2009 |
| Results First Received: | May 7, 2012 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
Burns Pain |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries Propranolol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents |
ClinicalTrials.gov processed this record on June 18, 2013