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TRAUMA HELP: Healing and Analgesia With Propranolol

Phase 2
Withdrawn
Conditions
Trauma
Interventions
Registration Number
NCT01007084
Lead Sponsor
University of North Carolina, Chapel Hill
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PropranololPropranolol-
PropranololPropranolol ER-
Sugar pillSugar pills-
Primary Outcome Measures
NameTimeMethod
Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.Study days 1, 3, 5, 7, 10, 13, 17, and 19
Secondary Outcome Measures
NameTimeMethod
Sleep qualityMOS Sleep Scale
Anxiety symptoms7 days, 6 weeks, 3 months, 6 months

Trial Locations

Locations (1)

University of North Carolina Trauma Center

🇺🇸

Chapel Hill, North Carolina, United States

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