Burns, Pain
Conditions
Keywords
Burns, Pain
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.
Interventions
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Pain Trajectory Slopes | Study days 5, 7, 10, 13, 17 and 19 | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 6 weeks after injury timepoint was chosen for this analysis | Medical Outcomes Survey Sleep Quality Subscale. This is a 0-10 numeric rating scale in which patients rate their sleep quality. 0 represents poor sleep quality whereas 10 represents a restful night of sleep. |
| Itch Symptoms | Week 6 after injury was chosen as the main timepoint of interest | Average itch intensity measured with a 0-10 numeric rating scale, 6 weeks was used as main outcome timepoint for itch symptom burden. 0 represents no itch symptoms and 10 represents the most severe itch symptoms. |
| Anxiety Symptoms | 6 weeks after injury was chosen as the main timepoint of interest | Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugar Pill Identical to active drug in sight, taste, and smell. | 23 |
| Propranolol, Propanolol ER Identical to sugar pill in sight, taste, and smell. | 22 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | Propranolol, Propanolol ER | Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 23 Participants | 45 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 9 | 32 years STANDARD_DEVIATION 11 | 32 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 22 participants | 23 participants | 45 participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 15 Participants | 19 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 23 | 8 / 22 |
| serious Total, serious adverse events | 1 / 23 | 0 / 22 |
Outcome results
Primary
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.
Time frame: Study days 5, 7, 10, 13, 17 and 19
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sugar Pill | Overall Pain Trajectory Slopes | -0.22 Numeric Rating Scale Score Change/Day |
| Propranolol, Propanolol ER | Overall Pain Trajectory Slopes | -0.16 Numeric Rating Scale Score Change/Day |
Secondary
Anxiety Symptoms
Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.
Time frame: 6 weeks after injury was chosen as the main timepoint of interest
Population: The number of patients represents the number of participants responding at 6 weeks after injury.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar Pill | Anxiety Symptoms | 15.27 units on scale | Standard Deviation 4.62 |
| Propranolol, Propanolol ER | Anxiety Symptoms | 14.23 units on scale | Standard Deviation 3.87 |
p-value: 0.48t-test, 2 sided
Secondary
Itch Symptoms
Average itch intensity measured with a 0-10 numeric rating scale, 6 weeks was used as main outcome timepoint for itch symptom burden. 0 represents no itch symptoms and 10 represents the most severe itch symptoms.
Time frame: Week 6 after injury was chosen as the main timepoint of interest
Population: The number of participants who reported itch at the 6 week time point are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar Pill | Itch Symptoms | 1.91 units on a scale | Standard Deviation 1.81 |
| Propranolol, Propanolol ER | Itch Symptoms | 2.61 units on a scale | Standard Deviation 2.89 |
p-value: 0.32t-test, 2 sided
Secondary
Sleep Quality
Medical Outcomes Survey Sleep Quality Subscale. This is a 0-10 numeric rating scale in which patients rate their sleep quality. 0 represents poor sleep quality whereas 10 represents a restful night of sleep.
Time frame: 6 weeks after injury timepoint was chosen for this analysis
Population: The number of participants who reported sleep quality at the 6 week time point are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugar Pill | Sleep Quality | 6.75 units on a scale | Standard Deviation 2.49 |
| Propranolol, Propanolol ER | Sleep Quality | 7.46 units on a scale | Standard Deviation 2.02 |
p-value: 0.36t-test, 2 sided