Assessment of Prepulse Inhibition for Shock Pain Reduction

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

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-06-30

Brief Summary

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Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's) is highly variable. It can be influenced by psychological factors, physical condition and the number of shocks delivered.

It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low voltage pulse (prepulse)prior to the delivery of a stronger shock.

A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a shock of equal energy without a prepulse.

Detailed Description

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Conditions

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Pain Awareness From ICD Shocks

Keywords

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Prepulse Defibrillator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Arbitrary Waveform Defibrillator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

18+ Approved indication for implantation of an ICD Able and willing to provide informed consent Independently complete and understand the Mini Mental State Evaluation

Exclusion Criteria

Pregnancy Cannot understand English or French Contraindicated for defibrillation testing because of risk of thromboembolism Deaf or hard of hearing, making the acute testing difficult to conduct having pain or anxiety to the extent that, in the opinion of the investigator, the results would be confounded.

Having a Class I bradycardia pacing indication, requiring ongoing pacing support.

Visual problems which preclude reading the computer screen for the VAS test Severe musculoskeletal disorder that makes it difficult to undergo testing in the recumbent position Do not achieve a score \>24/30 on a Mini Mental State Exam

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Douglas A Cameron, MD

Role: PRINCIPAL_INVESTIGATOR

UHN

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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04-0252-B

Identifier Type: -

Identifier Source: org_study_id