TRAUMA HELP: Healing and Analgesia With Propranolol
Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Trauma
Intervention: Propranolol (Drug); Propranolol ER (Drug); Sugar pills (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: University of North Carolina, Chapel Hill Official(s) and/or principal investigator(s): Samuel M McLean, MD MPH, Principal Investigator, Affiliation: UNC Chapel Hill School of Medicine
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.
Clinical Details
Official title: Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.
Secondary outcome: Sleep qualityAnxiety symptoms
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
University of North Carolina Trauma Center, Chapel Hill, North Carolina 27599, United States
Additional Information
Starting date: October 2009
Last updated: December 7, 2011
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