A Phase 2 interventional study of Propranolol and Placebo in Burns and Pain, sponsored by University of North Carolina, Chapel Hill. Completed at 4 sites in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by University of North Carolina, Chapel Hill · Phase 2, Interventional, and Treatment
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.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 45 is above the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: Propranolol · Drug: Propanolol
40 mg
Also known as: Inderal, Innopran
sugar pill
Also known as: Sugar pill
120 mg twice per day
Also known as: Inderal, Innopran
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
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
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
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
| Milestone | Sugar Pill | Propranolol, Propanolol ER |
|---|---|---|
| Started | 23 | 22 |
| Completed | 23 | 20 |
| Not completed | 0 | 2 |
| Withdrew: Adverse event | 0 | 2 |
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.
| Numeric Rating Scale Score Change/Day | Sugar Pill | Propranolol, Propanolol ER |
|---|---|---|
| Overall Pain Trajectory Slopes | -0.22 (-0.25 to -0.19) | -0.16 (-0.19 to -0.13) |
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.
| units on a scale | Propranolol | Placebo |
|---|---|---|
| Sleep Quality | 6.75 ± 2.49 | 7.46 ± 2.02 |
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.
| units on a scale | Propranolol | Placebo |
|---|---|---|
| Itch Symptoms | 1.91 ± 1.81 | 2.61 ± 2.89 |
Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.
| units on scale | Propranolol | Placebo |
|---|---|---|
| Anxiety Symptoms | 15.27 ± 4.62 | 14.23 ± 3.87 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugar Pill | — | 1/23 (4.3%) | 6/23 (26.1%) |
| Propranolol, Propanolol ER | — | 0/22 (0%) | 8/22 (36.4%) |
| Event | Sugar Pill | Propranolol, Propanolol ER |
|---|---|---|
| ThrombisisBlood and lymphatic system disorders | 1/23 | 0/22 |
| Event | Sugar Pill | Propranolol, Propanolol ER |
|---|---|---|
| NauseaGastrointestinal disorders | 6/23 | 8/22 |
| Age, Categorical(Participants) | Sugar Pill | Propranolol, Propanolol ER | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 22 | 45 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Sugar Pill | Propranolol, Propanolol ER | Total |
|---|---|---|---|
| Mean | 32 ± 11 | 31 ± 9 | 32 ± 10 |
| Sex: Female, Male(Participants) | Sugar Pill | Propranolol, Propanolol ER | Total |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 19 | 15 | 34 |
| Region of Enrollment(participants) | Sugar Pill | Propranolol, Propanolol ER | Total |
|---|---|---|---|
| United States | 23 | 22 | 45 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill