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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
September 8, 2005
September 19, 2005
November 14, 2006
May 2005
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Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock
Same as current
Complete list of historical versions of study NCT00193986 on ClinicalTrials.gov Archive Site
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Assessment of Prepulse Inhibition for Shock Pain Reduction
Assessment of Prepulse Inhibition for Shock Pain Reduction- Ventricular

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.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Pain Awareness From ICD Shocks
Device: Arbitrary Waveform Defibrillator
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2005
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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

Sexes Eligible for Study: All
18 Years to 88 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00193986
04-0252-B
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University Health Network, Toronto
  • Dr. Douglas Cameron
  • St. Jude Medical
Principal Investigator: Douglas A Cameron, MD UHN
University Health Network, Toronto
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP