Phase 2
N=45
Burn Healing and Analgesia With Propranolol
Burns · Pain
Bottom Line
View on ClinicalTrials.gov: NCT00934947 ↗Enrolled (actual)
45
Serious AEs
2.2%
Results posted
Oct 2012
Primary outcome: Primary: Overall Pain Trajectory Slopes — -0.22; -0.16 Numeric Rating Scale Score Change/Day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Propranolol (Drug); Placebo (Drug); Propanolol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Pain Trajectory Slopes |
-0.22; -0.16 | — |
| SECONDARY Sleep Quality |
6.75; 7.46 | .36 |
| SECONDARY Itch Symptoms |
1.91; 2.61 | .32 |
| SECONDARY Anxiety Symptoms |
15.27; 14.23 | .48 |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00934947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.