TRAUMA HELP: Healing and Analgesia With Propranolol

NCT ID: NCT01007084

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Trauma

Keywords

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pain trauma propranolol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Propranolol

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

40 mg

Propranolol ER

Intervention Type DRUG

120 mg twice per day

Sugar pill

Group Type PLACEBO_COMPARATOR

Sugar pills

Intervention Type DRUG

sugar pill

Interventions

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Propranolol

40 mg

Intervention Type DRUG

Propranolol ER

120 mg twice per day

Intervention Type DRUG

Sugar pills

sugar pill

Intervention Type DRUG

Other Intervention Names

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Inderal Innopran Inderal Innopran Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Samuel McLean, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel M McLean, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill School of Medicine

Locations

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University of North Carolina Trauma Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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09-1391

Identifier Type: -

Identifier Source: org_study_id