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TRAUMA HELP: Healing and Analgesia With Propranolol (TRAUMA_HELP)

Primary Purpose

Trauma

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Propranolol

Propranolol ER

Sugar pills

About this trial

This is an interventional treatment trial for Trauma focused on measuring pain, trauma, propranolol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of North Carolina Trauma Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propranolol

Sugar pill

Arm Description

Outcomes

Primary Outcome Measures

Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.

Secondary Outcome Measures

Sleep quality

Anxiety symptoms

Full Information

NCT ID

NCT01007084

First Posted

November 2, 2009

Last Updated

December 7, 2011

Sponsor

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT01007084

Brief Title

TRAUMA HELP: Healing and Analgesia With Propranolol

Acronym

TRAUMA_HELP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of eligible patient recruits/feasibility considerations.

Study Start Date

October 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma

Keywords

pain, trauma, propranolol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propranolol

Arm Type

Experimental

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Propranolol

Other Intervention Name(s)

Inderal, Innopran

Intervention Description

40 mg

Intervention Type

Drug

Intervention Name(s)

Propranolol ER

Other Intervention Name(s)

Inderal, Innopran

Intervention Description

120 mg twice per day

Intervention Type

Drug

Intervention Name(s)

Sugar pills

Other Intervention Name(s)

Placebo

Intervention Description

sugar pill

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Sleep quality

Time Frame

MOS Sleep Scale

Title

Anxiety symptoms

Time Frame

7 days, 6 weeks, 3 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel M McLean, MD MPH

Organizational Affiliation

UNC Chapel Hill School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina Trauma Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Learn more about this trial

TRAUMA HELP: Healing and Analgesia With Propranolol

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