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Burn Healing and Analgesia With Propranolol (BURN HELP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00934947
First Posted: July 8, 2009
Last Update Posted: November 16, 2017
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.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
Results First Submitted: May 7, 2012  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sugar Pill Identical to active drug in sight, taste, and smell.
Propranolol, Propanolol ER Identical to sugar pill in sight, taste, and smell.

Participant Flow:   Overall Study
    Sugar Pill   Propranolol, Propanolol ER
STARTED   23   22 
COMPLETED   23   20 
NOT COMPLETED   0   2 
Adverse Event                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Pill Identical to active drug in sight, taste, and smell.
Propranolol, Propanolol ER Identical to sugar pill in sight, taste, and smell.
Total Total of all reporting groups

Baseline Measures
   Sugar Pill   Propranolol, Propanolol ER   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   22   45 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 32  (11)   31  (9)   32  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  17.4%      7  31.8%      11  24.4% 
Male      19  82.6%      15  68.2%      34  75.6% 
Region of Enrollment 
[Units: Participants]
     
United States   23   22   45 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Pain Trajectory Slopes   [ Time Frame: Study days 5, 7, 10, 13, 17 and 19 ]

2.  Secondary:   Sleep Quality   [ Time Frame: 6 weeks after injury timepoint was chosen for this analysis ]

3.  Secondary:   Itch Symptoms   [ Time Frame: Week 6 after injury was chosen as the main timepoint of interest ]

4.  Secondary:   Anxiety Symptoms   [ Time Frame: 6 weeks after injury was chosen as the main timepoint of interest ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Samuel McLean
Organization: UNC Department of Anesthesiology
phone: 919-966-7315
e-mail: smclean@aims.unc.edu



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 16, 2017