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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Status: Withdrawn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


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 quality

Anxiety 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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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