TRAUMA HELP: Healing and Analgesia With Propranolol (TRAUMA_HELP)

December 7, 2011 updated by: Samuel McLean, MD, University of North Carolina, Chapel Hill

Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Trauma Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Sugar pill
Drug: Sugar pills
sugar pill
Other Names:
  • Placebo
EXPERIMENTAL: Propranolol
Drug: Propranolol
40 mg
Other Names:
  • Inderal
  • Innopran
Drug: Propranolol ER
120 mg twice per day
Other Names:
  • Inderal
  • Innopran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Study days 1, 3, 5, 7, 10, 13, 17, and 19

Secondary Outcome Measures

Outcome Measure
Time Frame
Sleep quality
Time Frame: MOS Sleep Scale
MOS Sleep Scale
Anxiety symptoms
Time Frame: 7 days, 6 weeks, 3 months, 6 months
7 days, 6 weeks, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

November 2, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (ESTIMATE)

November 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-1391

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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