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Burn Healing and Analgesia With Propranolol (BURN HELP)

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ClinicalTrials.gov Identifier: NCT00934947
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : October 29, 2012
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Burns
Pain
Interventions Drug: Propranolol
Drug: Placebo
Drug: Propanolol
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sugar Pill Propranolol, Propanolol ER
Hide Arm/Group Description Identical to active drug in sight, taste, and smell. Identical to sugar pill in sight, taste, and smell.
Period Title: Overall Study
Started 23 22
Completed 23 20
Not Completed 0 2
Reason Not Completed
Adverse Event             0             2
Arm/Group Title Sugar Pill Propranolol, Propanolol ER Total
Hide Arm/Group Description Identical to active drug in sight, taste, and smell. Identical to sugar pill in sight, taste, and smell. Total of all reporting groups
Overall Number of Baseline Participants 23 22 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
22
 100.0%
45
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 22 participants 45 participants
32  (11) 31  (9) 32  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
Female
4
  17.4%
7
  31.8%
11
  24.4%
Male
19
  82.6%
15
  68.2%
34
  75.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 22 participants 45 participants
23 22 45
1.Primary Outcome
Title Overall Pain Trajectory Slopes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill Propranolol, Propanolol ER
Hide Arm/Group Description:
Identical to active drug in sight, taste, and smell.
Identical to sugar pill in sight, taste, and smell.
Overall Number of Participants Analyzed 23 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Numeric Rating Scale Score Change/Day
-0.22
(-0.25 to -0.19)
-0.16
(-0.19 to -0.13)
2.Secondary Outcome
Title Sleep Quality
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who reported sleep quality at the 6 week time point are included in the analysis.
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:
Individuals who were randomized to receive propranolol following an intention to treat analysis
Individuals enrolled in the study who received placebo
Overall Number of Participants Analyzed 16 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.75  (2.49) 7.46  (2.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propranolol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .36
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Itch Symptoms
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who reported itch at the 6 week time point are included in the analysis.
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:
Individuals who were randomized to receive propranolol following an intention to treat analysis
Individuals enrolled in the study who received placebo
Overall Number of Participants Analyzed 16 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.91  (1.81) 2.61  (2.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propranolol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .32
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Anxiety Symptoms
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients represents the number of participants responding at 6 weeks after injury.
Arm/Group Title Propranolol Placebo
Hide Arm/Group Description:
Individuals who were randomized to receive propranolol following an intention to treat analysis
Individuals enrolled in the study who received placebo
Overall Number of Participants Analyzed 15 22
Mean (Standard Deviation)
Unit of Measure: units on scale
15.27  (4.62) 14.23  (3.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propranolol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .48
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill Propranolol, Propanolol ER
Hide Arm/Group Description Identical to active drug in sight, taste, and smell. Identical to sugar pill in sight, taste, and smell.
All-Cause Mortality
Sugar Pill Propranolol, Propanolol ER
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill Propranolol, Propanolol ER
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/23 (4.35%)      0/22 (0.00%)    
Blood and lymphatic system disorders     
Thrombisis  1/23 (4.35%)  1 0/22 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sugar Pill Propranolol, Propanolol ER
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/23 (26.09%)      8/22 (36.36%)    
Gastrointestinal disorders     
Nausea  6/23 (26.09%)  6 8/22 (36.36%)  8
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Samuel McLean
Organization: UNC Department of Anesthesiology
Phone: 919-966-7315
EMail: smclean@aims.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00934947     History of Changes
Other Study ID Numbers: 09-0681
First Submitted: July 6, 2009
First Posted: July 8, 2009
Results First Submitted: May 7, 2012
Results First Posted: October 29, 2012
Last Update Posted: November 17, 2017