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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar pill | Placebo Comparator |
| |
| Propranolol, Propanolol ER | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol | Drug | 40 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks after injury timepoint was chosen for this analysis |
| Itch Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel McLean, MD, MPh | University of North Carolina, Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20011 | United States | ||
| North Carolina Jaycee Burn Center |
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| Label | URL |
|---|---|
| NC Jaycee Burn Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill | Identical to active drug in sight, taste, and smell. |
| FG001 | Propranolol, Propanolol ER | Identical to sugar pill in sight, taste, and smell. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | Identical to active drug in sight, taste, and smell. |
| BG001 | Propranolol, Propanolol ER | Identical to sugar pill in sight, taste, and smell. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | Numeric Rating Scale Score Change/Day | Study days 5, 7, 10, 13, 17 and 19 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill | Identical to active drug in sight, taste, and smell. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombisis | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samuel McLean | UNC Department of Anesthesiology | 919-966-7315 | smclean@aims.unc.edu |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Placebo | Drug | sugar pill |
|
|
| Propanolol | Drug | 120 mg twice per day |
|
|
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. |
| Week 6 after injury was chosen as the main timepoint of interest |
| Anxiety Symptoms | Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety. | 6 weeks after injury was chosen as the main timepoint of interest |
| Chapel Hill |
| North Carolina |
| 27514 |
| United States |
| Wake Forest University Baptist | Wake Forest | North Carolina | 27587 | United States |
| Crozer Chester Medical Center | Upland | Pennsylvania | 19102 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | The number of participants who reported sleep quality at the 6 week time point are included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks after injury timepoint was chosen for this analysis |
|
|
|
|
| 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. | The number of participants who reported itch at the 6 week time point are included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 6 after injury was chosen as the main timepoint of interest |
|
|
|
|
| Secondary | Anxiety Symptoms | Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety. | The number of patients represents the number of participants responding at 6 weeks after injury. | Posted | Mean | Standard Deviation | units on scale | 6 weeks after injury was chosen as the main timepoint of interest |
|
|
|
|
| 1 |
| 23 |
| 6 |
| 23 |
| EG001 | Propranolol, Propanolol ER | Identical to sugar pill in sight, taste, and smell. | 0 | 22 | 8 | 22 |
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |