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Assessment of Prepulse Inhibition for Shock Pain Reduction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193986
First Posted: September 19, 2005
Last Update Posted: November 14, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dr. Douglas Cameron
St. Jude Medical
Information provided by:
University Health Network, Toronto
  Purpose

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.


Condition Intervention
Pain Awareness From ICD Shocks Device: Arbitrary Waveform Defibrillator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Assessment of Prepulse Inhibition for Shock Pain Reduction- Ventricular

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock

Estimated Enrollment: 10
Study Start Date: May 2005
Estimated Study Completion Date: June 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193986


Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Dr. Douglas Cameron
St. Jude Medical
Investigators
Principal Investigator: Douglas A Cameron, MD UHN
  More Information

ClinicalTrials.gov Identifier: NCT00193986     History of Changes
Other Study ID Numbers: 04-0252-B
First Submitted: September 8, 2005
First Posted: September 19, 2005
Last Update Posted: November 14, 2006
Last Verified: September 2006

Keywords provided by University Health Network, Toronto:
Prepulse
Defibrillator

Additional relevant MeSH terms:
Shock
Pathologic Processes