Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Completed
NCT Number: NCT00193986
Assessment of Prepulse Inhibition for Shock Pain Reduction
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–88 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Arbitrary Waveform Defibrillator
DevicePrimary outcomes
-
Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock
Sponsors and collaborators
Lead sponsor
University Health Network, Toronto
Other
Collaborators
- Abbott Medical Devices
- Dr. Douglas Cameron
Registry information
Official study title
Assessment of Prepulse Inhibition for Shock Pain Reduction- Ventricular
Important dates
- Study start
- 2005
- Study completion
- 2005
- First posted
- Sep 19, 2005
- Registry last updated
- Nov 14, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.