TRAUMA HELP: Healing and Analgesia With Propranolol (TRAUMA_HELP)

This study has been withdrawn prior to enrollment.
(Lack of eligible patient recruits/feasibility considerations.)
Information provided by (Responsible Party):
Samuel McLean, MD, University of North Carolina, Chapel Hill Identifier:
First received: November 2, 2009
Last updated: December 7, 2011
Last verified: December 2011

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 Intervention Phase
Drug: Propranolol
Drug: Propranolol ER
Drug: Sugar pills
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol

Resource links provided by NLM:

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep quality [ Time Frame: MOS Sleep Scale ] [ Designated as safety issue: No ]
  • Anxiety symptoms [ Time Frame: 7 days, 6 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT01007084

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
Principal Investigator: Samuel M McLean, MD MPH UNC Chapel Hill School of Medicine
  More Information

No publications provided

Responsible Party: Samuel McLean, MD, Principle Investigator, University of North Carolina, Chapel Hill Identifier: NCT01007084     History of Changes
Other Study ID Numbers: 09-1391
Study First Received: November 2, 2009
Last Updated: December 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

Additional relevant MeSH terms:
Wounds and Injuries
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents processed this record on April 16, 2014