Burn Healing and Analgesia With Propranolol (BURN HELP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00934947|
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : October 29, 2012
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Burns Pain||Drug: Propranolol Drug: Placebo Drug: Propanolol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||June 2011|
|Placebo Comparator: Sugar pill||
Other Name: Sugar pill
|Experimental: Propranolol, Propanolol ER||
120 mg twice per day
- Overall Pain Trajectory Slopes [ Time Frame: 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.
- Sleep Quality [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934947
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, D.C., 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|
|Principal Investigator:||Samuel McLean, MD, MPh||University of North Carolina, Department of Anesthesiology|