TRAUMA HELP: Healing and Analgesia With Propranolol (TRAUMA_HELP)

This study has been withdrawn prior to enrollment.
(Lack of eligible patient recruits/feasibility considerations.)
Sponsor:
Information provided by (Responsible Party):
Samuel McLean, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01007084
First received: November 2, 2009
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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
Trauma
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007084

Locations
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
Investigators
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
ClinicalTrials.gov 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:
pain
trauma
propranolol

Additional relevant MeSH terms:
Wounds and Injuries
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 01, 2014