Assessment of Prepulse Inhibition for Shock Pain Reduction

This study has been completed.
Sponsor:
Collaborators:
Dr. Douglas Cameron
St. Jude Medical
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00193986
First received: September 8, 2005
Last updated: November 13, 2006
Last verified: September 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00193986     History of Changes
Other Study ID Numbers: 04-0252-B
Study First Received: September 8, 2005
Last Updated: November 13, 2006
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Prepulse
Defibrillator

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014