Assessment of Prepulse Inhibition for Shock Pain Reduction

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Arbitrary Waveform Defibrillator

About this trial

This is an interventional prevention trial for Pain Awareness From ICD Shocks focused on measuring Prepulse, Defibrillator

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Toronto General Hospital

Outcomes

Primary Outcome Measures

Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock

Secondary Outcome Measures

Full Information

NCT ID

NCT00193986

First Posted

September 8, 2005

Last Updated

November 13, 2006

Sponsor

University Health Network, Toronto

Collaborators

Dr. Douglas Cameron, Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT00193986

Brief Title

Assessment of Prepulse Inhibition for Shock Pain Reduction

Official Title

Assessment of Prepulse Inhibition for Shock Pain Reduction- Ventricular

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Health Network, Toronto

Collaborators

Dr. Douglas Cameron, Abbott Medical Devices

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Pain Awareness From ICD Shocks

Keywords

Prepulse, Defibrillator

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

10 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Arbitrary Waveform Defibrillator

Primary Outcome Measure Information:

Title

Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

88 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas A Cameron, MD

Organizational Affiliation

UHN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Pain Awareness From ICD Shocks

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial