TRAUMA HELP: Healing and Analgesia With Propranolol (TRAUMA_HELP)
Primary Purpose
Trauma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propranolol
Propranolol ER
Sugar pills
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring pain, trauma, propranolol
Eligibility Criteria
Inclusion Criteria:
- at least one fracture
- ages 18-60 yrs
- pain score >= 4
- speak and read English
Exclusion Criteria:
- gunshot, stab wound, or assault
- paraplegia/quadriplegia
- pregnancy
- psychotic, suicidal, or homicidal
- hepatic, kidney failure
- clinically unstable or intubated at time of recruitment
- hyperthyroidism
- propranolol use within the last 6 months
- significant bradycardia
- cancer (except basal cell)
- peripheral vascular disease
- heart block > 1 degree
- breastfeeding
- congestive heart failure
Sites / Locations
- University of North Carolina Trauma Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Propranolol
Sugar pill
Arm Description
Outcomes
Primary Outcome Measures
Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.
Secondary Outcome Measures
Sleep quality
Anxiety symptoms
Full Information
NCT ID
NCT01007084
First Posted
November 2, 2009
Last Updated
December 7, 2011
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01007084
Brief Title
TRAUMA HELP: Healing and Analgesia With Propranolol
Acronym
TRAUMA_HELP
Official Title
Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of eligible patient recruits/feasibility considerations.
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether propranolol can decrease pain symptoms in a common subset of patients admitted to a trauma center after injury.
Detailed Description
The main purpose of this pilot study is to investigate Propranolol's utility in the trauma population. Specifically, to see if it reduces pain scores post-injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
Keywords
pain, trauma, propranolol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propranolol
Arm Type
Experimental
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
Inderal, Innopran
Intervention Description
40 mg
Intervention Type
Drug
Intervention Name(s)
Propranolol ER
Other Intervention Name(s)
Inderal, Innopran
Intervention Description
120 mg twice per day
Intervention Type
Drug
Intervention Name(s)
Sugar pills
Other Intervention Name(s)
Placebo
Intervention Description
sugar pill
Primary Outcome Measure Information:
Title
Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.
Time Frame
Study days 1, 3, 5, 7, 10, 13, 17, and 19
Secondary Outcome Measure Information:
Title
Sleep quality
Time Frame
MOS Sleep Scale
Title
Anxiety symptoms
Time Frame
7 days, 6 weeks, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least one fracture
ages 18-60 yrs
pain score >= 4
speak and read English
Exclusion Criteria:
gunshot, stab wound, or assault
paraplegia/quadriplegia
pregnancy
psychotic, suicidal, or homicidal
hepatic, kidney failure
clinically unstable or intubated at time of recruitment
hyperthyroidism
propranolol use within the last 6 months
significant bradycardia
cancer (except basal cell)
peripheral vascular disease
heart block > 1 degree
breastfeeding
congestive heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel M McLean, MD MPH
Organizational Affiliation
UNC Chapel Hill School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Trauma Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TRAUMA HELP: Healing and Analgesia With Propranolol
We'll reach out to this number within 24 hrs