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TRAUMA HELP: Healing and Analgesia With Propranolol

Information source: University of North Carolina, Chapel Hill
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Trauma

Intervention: Propranolol (Drug); Propranolol ER (Drug); Sugar pills (Drug)

Phase: Phase 2

Status: Recruiting

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

Overall contact:
April J Soward, MPH, Phone: 866-939-0267, Email: traumahelp@unc.edu

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, Control: Placebo Control, 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.

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

April J Soward, MPH, Phone: 866-939-0267, Email: traumahelp@unc.edu

University of North Carolina Trauma Center, Chapel Hill, North Carolina 27599, United States; Recruiting
April Soward, MPH, Phone: 919-966-8020
Samuel McLean, MD, MPH, Principal Investigator
Additional Information

Starting date: October 2009
Last updated: December 14, 2009

Page last updated: October 04, 2010

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