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TRAUMA HELP: Healing and Analgesia With Propranolol (TRAUMA_HELP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01007084
Recruitment Status : Withdrawn (Lack of eligible patient recruits/feasibility considerations.)
First Posted : November 3, 2009
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):
Samuel McLean, MD, 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.

Condition or disease Intervention/treatment Phase
Trauma Drug: Propranolol Drug: Propranolol ER Drug: Sugar pills Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol
Study Start Date : October 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Propranolol Drug: Propranolol
40 mg
Other Names:
  • Inderal
  • Innopran

Drug: Propranolol ER
120 mg twice per day
Other Names:
  • Inderal
  • Innopran

Placebo Comparator: Sugar pill Drug: Sugar pills
sugar pill
Other Name: Placebo

Primary Outcome Measures :
  1. 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 Measures :
  1. Sleep quality [ Time Frame: MOS Sleep Scale ]
  2. Anxiety symptoms [ Time Frame: 7 days, 6 weeks, 3 months, 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007084

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United States, North Carolina
University of North Carolina Trauma Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Samuel M McLean, MD MPH UNC Chapel Hill School of Medicine

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Responsible Party: Samuel McLean, MD, Principle Investigator, University of North Carolina, Chapel Hill Identifier: NCT01007084     History of Changes
Other Study ID Numbers: 09-1391
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011
Keywords provided by Samuel McLean, MD, University of North Carolina, Chapel Hill:
Additional relevant MeSH terms:
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Wounds and Injuries
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents